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Class 2 Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and

Discussion in 'Product Recalls' started by Ellen, Sep 3, 2014.

  1. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.

    [h=1]Class 2 Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System[/h][h=1][/h]

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    [TD="width: 34%, align: left"]Class 2 Recall
    Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System[/TD]
    [TD="width: 33%, align: right"] [​IMG][/TD]
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    [TH]Date Posted[/TH]
    [TD]August 22, 2014[/TD]
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    [TH]Recall Status1[/TH]
    [TD]Open[/TD]
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    [TH]Recall Number[/TH]
    [TD]Z-2544-2014[/TD]
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    [TH]Recall Event ID[/TH]
    [TD]68277[/TD]
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    [TH]Premarket Approval
    PMA Numbers[/TH]
    [TD] P120010 P980022 [/TD]
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    [TH]Product Classification[/TH]
    [TD] Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor - Product Code OYC
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    [TH]Product[/TH]
    [TD="class: hardbreak"]Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.[/TD]
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    [TH]Code Information[/TH]
    [TD]Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
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    [TH]Recalling Firm/
    Manufacturer[/TH]
    [TD]Medtronic MiniMed Inc.
    18000 Devonshire St
    Northridge, California 91325-1219[/TD]
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    [TH]Manufacturer Reason
    for Recall[/TH]
    [TD]Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount. [/TD]
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    [TH]FDA Determined
    Cause 2[/TH]
    [TD]DESIGN: Device Design [/TD]
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    [TH]Action[/TH]
    [TD]The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement. [/TD]
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    [TH]Quantity in Commerce[/TH]
    [TD]559,374 units total (444,374 units in US)[/TD]
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    [TH]Distribution[/TH]
    [TD]Worldwide Distribution-Nationwide in US[/TD]
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    [TH="align: left"]Total Product Life Cycle[/TH]
    [TD="align: left"] TPLC Device Report [/TD]
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    [TD="colspan: 2"] 1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
    2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. [/TD]
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    [TH]PMA Database[/TH]
    [TD] PMAs with Product Code = OYC and Applicant = MEDTRONIC INC.
    PMAs with Product Code = OYC and Applicant = MEDTRONIC MINIMED
    PMAs with Product Code = OYC and Applicant = MEDTRONIC MINIMED, INC.
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