BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2990818 · Received March 5, 2013

    Report

    Report Number
    2531779-2013-02395
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE BATTERY COMPARTMENT THREADS WERE STRIPPED AND THE CAP WAS GETTING STUCK. THE BATTERY CAP THREADS WERE STRIPPED AND THE BATTERY CAP HEIGHT AND WIDTH WERE OUT OF SPECIFICATIONS. THE O-RING WAS MISSING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY CAP HEIGHT AND WIDTH WERE OUT OF SPECIFICATIONS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93768 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR