BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3410229 · Received October 15, 2013

    Report

    Report Number
    2531779-2013-17577
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    September 27, 2013
    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 BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/26/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THE 0.00U BASAL RATE ON (B)(6) 2013 08:54 WAS RECORDED DUE TO A REPLACE CARTRIDGE¿ ALARM ON (B)(6) 2013 08:51. DURING TESTING, THE PUMP POWERED ON NORMALLY. A 1.0 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED IN THE PUMP FOR A 24HR DURATION PERIOD WITH NO ERRORS, ALARMS, OR WARNINGS. AT THE END OF THE EXERCISE THE PUMP WAS STILL DELIVERING AT THE 1 UNIT PER HOUR BASAL RATE AND THE RATES WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. 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.

    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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE BASAL RATE WAS 0.0 WITHOUT MAKING ANY CHANGES TO THE BASAL RATE SETTINGS. 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
    528670 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR