BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4222271 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31348
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    FOLLOW-UP #1 DATE OF SUBMISSION 01/26/2015-PRODUCT ANALYSIS:THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/12/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS UNABLE TO BE INVESTIGATED DUE TO AN UNRELATED ISSUE. REVIEW OF THE PUMP¿S BLACK BOX REVEALED SIX MANUAL TIME CHANGES. THE PUMP MAINTAINED ACCURATE TIME FOR 5 DAYS. WHEN THE BATTERY WAS REMOVED FOR 1 HOUR, THE TIME AND DATE RESET TO DEFAULT. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME LOSS/GAIN) 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
    702944 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR