BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082837 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05508
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) RANGING BETWEEN 29 MG/DL AND 50 MG/DL SEVERAL WEEKS PRIOR. THE PATIENT REFUSED TO TROUBLESHOOT THE ISSUE WITH ANIMAS CUSTOMER TECHNICAL SUPPORT AT THE TIME OF THE CALL. THE PATIENT'S CURRENT BG WAS NOT REPORTED DURING THE CALL. THE PATIENT MADE NO ALLEGATION AGAINST THE PUMP. THE PATIENT REMAINED ON INSULIN PUMP THERAPY AND THE PUMP IS NOT BEING RETURNED TO ANIMAS FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WHILE ON INSULIN PUMP THERAPY WITHOUT A KNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185173 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR