BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2163086 · Received July 15, 2011

    Report

    Report Number
    2531779-2011-04959
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/10/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. A REVIEW OF THE PUMP HISTORY DID NOT INDICATE THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. RECALL 2531779-03/24/2010-003-R. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EMITTING LOSS OF PRIME ALARMS MULTIPLE TIMES PER DAY. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/10/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY. THIS REPORT IS BEING MADE BASED ON THE INVESTIGATION RESULTS.

    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 8 YR