BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2041658 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01466
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 9, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED A DIMPLED FORCE PLATE HOUSING AND OUT OF CALIBRATION FORCE SENSOR. A REVIEW OF THE PUMP HISTORY REVEALED 064-0001 ALARMS WHICH WERE NOT DUPLICATED DURING TESTING. UNRELATED TO COMPLAINT, DURING TESTING A CRACKED BATTERY COMPARTMENT WAS OBSERVED WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS 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 WAS RETURNED DUE TO LOSS OF PRIME AND 064-0001 ALARMS. EVAL REVEALED A DAMAGED FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. 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