BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3150161 · Received June 6, 2013

    Report

    Report Number
    2531779-2013-07844
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 462 MG/DL WITH NAUSEA, INCREASED URINATION AND INCREASED THIRST. THERE WAS REPORTEDLY A CRACK IN THE PUMP CASING AND THE PUMP WAS INTERMITTENTLY LOSING POWER. THE PATIENT REPORTEDLY CHANGED THE BATTERY MULTIPLE TIMES, THE PUMP WOULD BEEP, THE VERIFICATION SCREEN WOULD COME ON AND THEN THE DISPLAY SCREEN WENT BLANK. THE PATIENT STATED THAT SHE NEVER REPLACED THE BATTERY CAP AND THAT THE YELLOW O-RING WAS VISIBLE. THE PATIENT REPORTEDLY HAD OTHER HEALTH CONDITIONS UNRELATED TO DIABETES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. ADDITIONALLY, THE PUMP WAS REPORTEDLY DAMAGED, THE PUMP REPORTEDLY HAD INTERMITTENT POWER ISSUES AND THE PATIENT CONTINUED TO USE A DAMAGED PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250060 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening