BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3133128 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07127
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. IT WAS OBSERVED THAT THE KEYPAD WAS LIFTING FROM THE KEYPAD BASE, THE BUTTONS WERE DAMAGED AND THERE WAS EVIDENCE OF KEYPAD CONTAMINATION UNDER ALL THE BUTTONS. UNRELATED TO THE COMPLAINT THE BOLUS BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONSIVE DURING TESTING AND A HOLE WAS OBSERVED IN THE RUBBER. ON INVESTIGATION THE INTERNAL PLUG CONTACT WAS MISALIGNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. 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
    234338 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR