BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3120073 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06684
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE PUMP¿S HISTORY SHOWED EVIDENCE OF LOSS OF PRIME ASSOCIATED WITH LOW NON-ZERO FORCE. DURING TESTING, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE DURING THE LOAD STEP. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE OUT OF SPECIFICATIONS. THE PUMP WAS OPEN AND THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED AND CONTAMINATION WAS FOUND. UNRELATED TO THE FORCE SENSOR ISSUE, INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PUMP EXPELLED ALL OF THE INSULIN DURING THE LOAD STEP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221399 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR