BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1821773 · Received August 26, 2010

    Report

    Report Number
    2531779-2010-01110
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE FORCE SENSOR RESISTANCE MEASUREMENT WAS OUT OF CALIBRATION. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME WARNINGS. AFTER PERFORMING THE LOAD STEP DURING THE PRIMING PROCESS, THE PUMP GIVES A "NO PRIME" WARNING.

    Description of Event or Problem · 1

    EVALUATION REVEALED THAT THE FORCE SENSOR RESISTANCE MEASUREMENT 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. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR