BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1903000 · Received November 12, 2010

    Report

    Report Number
    2531779-2010-02285
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 14, 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
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN. THE FORCE SENSOR PINS WERE INTACT HOWEVER, THE FORCE SENSOR CONNECTION TO THE PCB WAS DEFECTIVE. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE. THE PUMP WAS PRIMED SUCCESSFULLY AND EXERCISED WITH NO ALARMS OCCURRING.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN. THE FORCE SENSOR PINS WERE INTACT HOWEVER THE FORCE SENSOR CONNECTION TO THE PCB WAS DEFECTIVE.

    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