BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3842129 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15297
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-PRODUCT ANALYSIS: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WOULD NOT POWER ON. THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN LENS. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP. THERE WAS NO EVIDENCE OF MOISTURE WITHIN THE BATTERY COMPARTMENT. THERE WAS EVIDENCE OF MOISTURE WITHIN THE PUMP¿S INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON COVER WAS FOUND TO BE MISSING. A LEAK WAS OBSERVED AT THE MISSING BOLUS BUTTON COVER DURING LEAK TESTING.

    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 (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THE PUMP WOULD NOT POWER ON AND THERE WAS EVIDENCE OF MOISTURE INGRESS BEHIND THE DISPLAY SCREEN. 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
    320442 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR