BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780865 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11840
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT POWER REBOOTS WERE RECORDED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED EXTENDING FROM THE THREADS TO THE CASE SEAL. THE RETURNED BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP DUE TO THE BATTERY CAP THREADS BEING STRIPPED. POWER LOSSES OCCURRED USING THE RETURNED BATTERY CAP. NO VISIBLE MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT OR IN THE DISPLAY SCREEN. A TEST BATTERY CAP WAS ABLE TO ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. THE PUMP WAS EXERCISED FOR 24 HOURS USING THE TEST BATTERY CAP WITH NO POWER ISSUES OCCURRING. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE WAS FOUND ON THE PRINTED CIRCUIT BOARD OR ON ANY OTHER INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE INTERNAL CLOCK BATTERY WAS LEAKING. A REVIEW OF THE PUMP¿S BLACK BOX HISTORY CONFIRMED THAT THE PUMP TIME AND DATE WAS RESETTING WITH POWER REBOOTS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT. 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
    260890 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR