BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2142351 · Received June 28, 2011

    Report

    Report Number
    2531779-2011-04526
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE WORN BUT INTACT; NO PEELING OR LIFTING WAS OBSERVED. INSPECTION REVEALED THAT THE BUTTON SYMBOLS ARE WORN. EVALUATION CONFIRMED THAT THE OK KEYPAD BUTTON IS INTERMITTENTLY RESPONSIVE. SCROLLING WAS NOT OBSERVED DURING TESTING. DURING INVESTIGATION, IT WAS NOTED THAT NONE OF THE KEYPAD BUTTONS HAVE NORMAL SPRING BACK, AND THE OK BUTTON CONTACT WAS FOUND TO BE MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE OK KEYPAD BUTTON BECAME INTERMITTENTLY UNRESPONSIVE LAST WEEK. SHE NOTED THAT THE OK BUTTON HAD A DELAYED RESPONSE, AND STATED THAT WHEN IT DOES RESPOND, THE PUMP SCROLLS THROUGH VARIOUS SCREENS.

    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 48 YR