BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2990962 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02392
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 INVESTIGATION CS 128-FB88 (REPLACE BATTERY) WAS VERIFIED IN ALARM HISTORY AND THE 128-FB88 ALARM COULD NOT BE DUPLICATED WHEN REWIND WAS SELECTED. SECONDARY ERROR CODE FB88, IS DEFINED AS A POST DELIVERY MOTOR POWER SUPPLY FAULT. THE BATTERY COMPARTMENT WAS CRACKED AT. THE BATTERY CAP THREADS WERE FOUND TO BE STRIPPED. THE BATTERY CAP HEIGHT WAS FOUND TO BE OUT OF SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION THAT THE BATTERY CAP HEIGHT WAS 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
    95469 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR