BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2285733 · Received October 11, 2011

    Report

    Report Number
    2531779-2011-07490
    Event Type
    Malfunction
    Date Received
    October 11, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 09/14/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR. DURING EVALUATION LOSS OFF CARTRIDGE DETECTION DID NOT OCCUR. RECALL - 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP WOULD NOT PRIME. THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 09/14/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THIS REPORT IS BEING MADE BASED ON RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR