BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4101390 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26799
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 11/17/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTED TO THE VERIFY SCREEN WITH AUDIO AND VIBRATION FEATURES. THE PUMP WAS EXERCISED FOR 24 HOURS AT 1.0 UNIT/HOUR BASAL RATE WITH NO ERRORS, ALARMS, OR WARNINGS OCCURRING AT THIS TIME. THE BATTERY WAS REMOVED FOR 5 MINUTES AT THE END OF 24 HOURS TO SIMULATE A BATTERY CHANGE. THE BATTERY WAS REPLACED AND THE PUMP POWERED ON WITH THE 1.0 UNIT BASAL RATE PROGRAMMED IN THE PUMP WITH NO CHANGES OBSERVED. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. THE RETURNED BATTERY AND CARTRIDGE CAPS WERE USED TO COMPLETE TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP WAS NOT HOLDING THE BASAL SETTINGS AFTER A BATTERY CHANGE. 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
    582744 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR