BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3871763 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16842
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES FUNCTIONAL. THE DISPLAY WAS FOUND TO BE BLANK AND THE PUMP¿S VIBRATION ALARMS DID NOT FUNCTION. NO EVIDENCE OF MOISTURE WAS OBSERVED FROM THE OUTSIDE OF THE PUMP. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE FOUND. THE PUMP CASE WAS REMOVED AND MOISTURE WAS FOUND ON THE DISPLAY CONNECTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED 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
    350411 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR