BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140523 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04476
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP WAS WARM WHEN THE PATIENT PULLED IT OUT OF PUMP POUCH. THERE WERE NO INJURIES DUE TO THIS ISSUE. THE PATIENT REPORTEDLY PLAYED IN THE SPRINKLER EARLIER IN THE DAY. THE PUMP BATTERY COMPARTMENT AND BATTERY REPORTEDLY HAD BROWN AND BLACK RESIDUE EVIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR