BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913409 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02583
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARS TO BE INTACT NO LIFTING OR PEELING OBSERVED. THE "UP/DOWN/OK" AND "CONTRAST" KEYPAD BUTTONS ARE INTERMITTENTLY RESPONDING DURING TESTING. THE "UP/DOWN" KEYPAD BUTTONS REQUIRE EXCESSIVE FORCE TO ACTIVATE DURING TESTING. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION, THE "UP" AND "CONTRAST" KEY CONTACTS ARE MISALIGNED. THE "UP/DOWN/CONTRAST" AND "OK" KEY CONTACTS BECOMES INVERTED WHEN PRESSED AND DO NOT ALWAYS SPRING BACK. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    THE LAY-USER/REPORTER ALLEGED THAT THE OK BUTTON IS STICKING. DURING TROUBLESHOOTING, CUSTOMER SERVICE NOTED THE ONLY THE OK BUTTON WAS AFFECTED. THE PROBLEM ISSUE BEGAN WEEKS AGO. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1