BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913521 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02512
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    August 24, 2010
    Report Date
    October 25, 2010
    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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. THE PUMP DID NOT DETECT THE CARTRIDGE ON THE LOAD STEP DURING EVAL AND EMITTED A "NO CARTRIDGE DETECTED" ALARM. THERE WERE MULTIPLE LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE IN THE PUMP HISTORY.

    Description of Event or Problem · 1

    EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND DISLODGED FORCE SENSOR PINS.

    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 54 YR