BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192755 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09090
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS NOTED THE SCHOOL NURSE DID NOT WANT THE INSULIN TO GO BAD SO SHE PUT THE PUMP IN THE REFRIGERATOR. THE PATIENT REPORTEDLY TRIED TO POWER BACK ON THE PUMP AND WAS UNABLE TO. THE ISSUE REPORTEDLY CONTINUED FOR 2 WEEKS EVEN AFTER MULTIPLE BATTERY REPLACEMENTS. THE PATIENT REPORTEDLY IS ON A BACK-UP PLAN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292827 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR