BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1810954 · Received August 9, 2010

    Report

    Report Number
    2531779-2010-00889
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 6, 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
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED A MISALIGNED DISPLAY SCREEN AND DISLODGED FORCE SENSOR PINS. EVAL ALSO REVEALED A DAMAGED FORCE SENSOR PLATE. THE PUMP WAS PRIMED AND EXERCISED WITH NO ALARMS DUPLICATED.

    Description of Event or Problem · 1

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

    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 49 YR