BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760717 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10670
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING RESULTS: A REVIEW OF THE BLACK BOX SHOWED AN UNACKNOWLEDGED EMPTY CARTRIDGE ALARM ON (B)(6) 2014 AT 3:16 PM; THE ALARM WENT UNACKNOWLEDGED UNTIL 4:59 PM. THE PUMP¿S SETTINGS CONFIRMED THAT THE INSULIN ON BOARD WAS SET TO 4 HOURS. USING THE USER¿S SETTINGS, A 2.4 BOLUS WAS PERFORMED. THE INSULIN ON BOARD CALCULATED ACCURATELY DURING TESTING. THE INACCURATE INSULIN ON BOARD WAS DUE TO UNACKNOWLEDGED ALARMS.

    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. 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
    240305 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR