BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3894093 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18239
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE USER¿S SETTINGS SHOWED THAT THE INSULIN ON BOARD (IOB) DURATION WAS SET TO SIX HOURS. DURING TESTING, AN EXERCISE WAS PERFORMED WITH 10 UNIT BOLUS AND A DURATION PERIOD OF 2.0 HOURS. AFTER THE 2 HOURS THE IOB STATUS WAS 0.00 AND THIS WAS ACCURATELY REFLECTED IN THE IOB STATUS. THE INSULIN ON BOARD FEATURE WAS FOUND TO BE FUNCTIONING PROPERLY AND THE COMPLAINT WAS NOT DUPLICATED.

    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 (INSULIN ON BOARD CALCULATION) ISSUE. THE INSULIN ON BOARD DURATION WAS REPORTEDLY SET TO SIX HOURS. THE REPORTER ALLEGED THAT BEFORE BOLUSES FOR THE PAST FEW MONTHS THE INSULIN ON BOARD WOULD BE AT ZERO, EVEN WHEN IT HAD NOT BEEN SIX HOURS SINCE THE LAST BOLUS. THE REPORTER COULD NOT CONFIRM IF THIS OCCURRED WITH EVERY BOLUS. 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
    371974 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR