BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3943644 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20592
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/08/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE PUMP¿S BLACK BOX REVEALED UNEXPLAINED REBOOTING EVENTS. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE BATTERY CAP THREADS WERE DAMAGED; THE CAP WAS UNABLE TO PROPERLY SECURE TO THE PUMP AND REBOOTING WAS DUPLICATED. THE TEST BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP AND THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. NO POWER ISSUES WERE OBSERVED WITH THE TEST CAP. THERE WAS NO EVIDENCE OF MOISTURE OR DAMAGE TO THE PUMP¿S INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BOLUS BUTTON COVER WAS TORN; NO RESPONSE ISSUES WERE EXPERIENCED WITH THE BOLUS BUTTON. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN INTERMITTENT POWER ISSUE AND BATTERY COMPARTMENT DAMAGE. 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
    422509 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR