BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2170654 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05096
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, THE AUDIO BOLUS BUTTON IS NOT WORKING AS WELL AS THE OK AND DOWN BUTTONS. ACCORDING TO THE PATIENT, THE ANIMAS PUMP IS PROGRAMMED AND IS DELIVERING ACCURATE DOSAGE. THERE WAS NO EVIDENCE OF PEELING OR DAMAGE TO THE KEYPAD. THE KEYPAD RESPONSE IS INTERMITTENTLY. THE PATIENT WAS ADVISED TO GO WITH THE BACKUP PLAN ACCORDINGLY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE REPORTED ISSUE. THE PRODUCT IS BEING RETURN FOR INVESTIGATION.

    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 36 YR