BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3813378 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13725
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/04/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/30/2014 WITH THE FOLLOWING RESULTS:A REVIEW OF THE BLACK BOX SHOWED A SUDDEN VOLTAGE DROP ON 05/09/2014. THE PUMP POWERED ON NORMALLY DURING TESTING; THE BATTERY COMPARTMENT AND RETURNED BATTERY CAP WERE INTACT. THE PUMP¿S CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATIONS AND NO EXCESSIVE TEMPERATURE ISSUE WAS DUPLICATED DURING TESTING. THE PUMP COVER WAS OPENED AND NO INTERNAL DEFECTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 TEMPERATURE ISSUE. THERE WAS ALLEGEDLY NO DAMAGE TO THE PUMP. 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
    290120 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR