BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1810948 · Received August 9, 2010

    Report

    Report Number
    2531779-2010-00888
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE FORCE SENSOR PLATE WAS VISIBLY DAMAGED. THE FORCE SENSOR RESISTANCE WAS TESTED AND FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS EXERCISED AND DID NOT EMIT ANY ALARMS.

    Description of Event or Problem · 1

    EVALUATION REVEALED THAT THE FORCE SENSOR PLATE WAS VISIBLY DAMAGED AND THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION.

    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 30 YR