BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4962638 · Received August 3, 2015

    Report

    Report Number
    2531779-2015-26694
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 9/23/15 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. THE FOLLOWING MANUAL TIME CHANGES OBSERVED IN THE BLACK BOX ON (B)(6) 2015: FROM 10:07AM TO 11:09AM; FROM 11:34AM TO 10:36AM AND ON (B)(6) 2015: FROM 4:14PM TO 1:14PM; THEN FROM 1:14PM TO 4:14PM. RETURNED BATTERY CAP USED FOR INVESTIGATION. A TIMEKEEPING ACCURACY TEST WAS PERFORMED; THE PUMP WAS KEEPING TIME ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME LOSS/GAIN) 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
    505045 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR