BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042853 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02068
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING TESTING, THE PUMP WAS REWOUND, LOADED AND PRIMED SUCCESSFULLY. DURING EVAL THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. UNRELATED TO THE COMPLAINT, THE BATTERY CAP WAS FOUND TO HAVE STRIPPED THREADS AND WOULD NOT KEEP CONTACT CAUSING POWER LOSS. THE USER GUIDE INSTRUCTS THE PT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/ OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR A SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. EVAL REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON THE EVAL RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1