BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3951978 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21058
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: THE RETURNED BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION DUE TO THE CAP DETACHING, SO A TEST CAP WAS USED FOR ALL TESTING. THE RETURNED BATTERY CAP HAD DAMAGED THREADS. THERE WAS A BATTERY COMPARTMENT CRACK WITH EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE COMPARTMENT. THE BLACK BOX HISTORY REVEALED VOLTAGE DROPS AND FLUCTUATIONS WITH UNEXPLAINABLE PUMP REBOOTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. THE LEAK TEST CONFIRMED THE LEAK AT THE BATTERY COMPARTMENT. THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION INSIDE THE PUMP WHEN THE CASE WAS REMOVED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE THERE WAS A CRACK IN THE BATTERY COMPARTMENT WITH MOISTURE OBSERVED INSIDE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431125 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR