BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1812845 · Received August 12, 2010

    Report

    Report Number
    2531779-2010-00916
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 17, 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
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED VISIBLE MOISTURE INGRESS IMPACTING THE FORCE SENSOR SOCKETS AND THE FORCE SENSOR ASSEMBLY. THE FORCE SENSOR RESISTANCE READING WAS FOUND TO BE OUT OF CALIBRATION. REVIEW OF THE PUMP HISTORY REVEALED "NO CARTRIDGE DETECTED" WARNINGS THAT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR