BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3050027 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-03955
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    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. 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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 03/23/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/10/2015 WITH THE FOLLOWING FINDINGS:THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE ALLEGED ISSUE COULD NOT BE VERIFIED OR DUPLICATED ON INVESTIGATION. THERE WAS EVIDENCE OF MOISTURE DAMAGE FOUND IN THE BATTERY COMPARTMENT. LEAK TESTING REVEALED A BATTERY COMPARTMENT LEAK. THE PUMP WAS OPENED AND THERE WAS EVIDENCE OF MOISTURE DAMAGE INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE BATTERY HAD EXPLODED IN THE PUMP. THE DISTRIBUTOR STATED THAT THE PATIENT REMOVED THE BATTERY CAP FOR A ROUTINE BATTERY CHANGE AND FOUND THAT THE TOP OF THE BATTERY HAD SEPARATED FROM THE BODY OF THE BATTERY. UPON INSPECTING THE PUMP, A CRACK WAS FOUND IN THE BATTERY COMPARTMENT. 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
    151990 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1