BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983085 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22516
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: MULTIPLE INEXPLICABLE POWER REBOOT EVENTS, WHICH ARE POTENTIALLY INDICATIVE OF THE REPORTED EVENT, WERE OBSERVED IN THE BLACK BOX DATA. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD, AND THE THREADS OF THE BATTERY CAP WERE DAMAGED. EVIDENCE OF MOISTURE INGRESS WAS OBSERVED INSIDE OF THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS UNABLE TO PROPERLY FASTEN TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU). THE PUMP WAS EXERCISED FOR 24 HOURS, WITH NO CALL SERVICE ALARMS, REBOOT EVENTS, OR LOSS OF POWER EVENTS OBSERVED; THE REPORTED EVENT WAS NOT DUPLICATED. THE PUMP PASSED A LEAK TEST. THE PUMP CASE WAS REMOVED, AND NO FURTHER EVIDENCE OF MOISTURE INGRESS WAS OBSERVED. THE RELATION OF THESE DEVICE FAILURES TO THE REPORTED EVENT COULD NOT BE DETERMINED, AS THE REPORTED EVENT WAS NOT DUPLICATED.

    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.

    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 MOISTURE WAS EVIDENT IN THE BATTERY COMPARTMENT. REPORTEDLY, THE THREADS OF THE BATTERY CAP WERE STRIPPED. IT WAS REPORTED THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT-POWER ISSUE. 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
    460997 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR