BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4212178 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30817
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 14, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN WITH AUDIO TONES AND VIBRATIONS FUNCTIONAL. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE. AT THE END OF THE DURATION EXERCISE THE BATTERY WAS REMOVED TO SIMULATE A BATTERY CHANGE. WHEN THE BATTERY WAS REINSERTED THE 1.0 UNIT PER HOUR BASAL RATE WAS RETAINED IN THE PUMP SETTINGS. THE COMPLAINT THAT THE PUMP WAS NOT MAINTAINING PROGRAMMED BASAL RATES AFTER BATTERY CHANGES WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND.

    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 HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS NOT MAINTAINING THE PROGRAMMED BASAL RATES WITH BATTERY CHANGES. 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
    692034 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR