BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3252934 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12030
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/16/2013 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP. POWER ON RESETS OBSERVED IN THE BLACK BOX REVIEW. NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. A NEW TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP UNTIL RESISTANCE WAS MET; NO YELLOW O RING WAS VISIBLE. A 1.0U/HR BASAL PROGRAM WAS EXECUTED IN THE PUMP FOR A 24 HOUR DURATION PERIOD USING THE NEW TEST BATTERY CAP; NO POWER INTERRUPTIONS OR ALARMS WERE DUPLICATED DURING THIS TIME. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND INSERTED A NEW TEST SCREEN. THE TEST SCREEN POWERS ON TO THE VERIFY SCREEN WITH NORMAL CONTRAST AND NO DISCOLORATION. NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS OBSERVED. A VISIBLE INSPECTION OF THE BT1 INTERNAL BATTERY CONFIRMED IT WAS LEAKING. THE POWER ISSUE WAS CONFIRMED IN THE BLACK BOX BUT WAS NOT DUPLICATED DURING THE INVESTIGATION. THERE WAS ALSO AN UNIDENTIFIED DISPLAY FAILURE. THE OK KEYPAD SYMBOL WAS FOUND TO BE WORN. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER CONTACTED ANIMAS ALLEGING THAT THEIR PUMP WAS LOSING POWER AND RESTARTING OFTEN. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353541 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR