BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3954699 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21232
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/26/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS PEELING OFF THE BASE OF THE PUMP. THE UP ARROW KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED, AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM, FADED, AND DISCOLORED AND THAT THE BATTERY COMPARTMENT WAS CRACKED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP ARROW KEYPAD BUTTON WAS UNDER-RESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432979 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1