BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3994154 · Received August 8, 2014

    Report

    Report Number
    2531779-2014-22844
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/04/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY REVEALED A ¿LOSS OF PRIME¿ WARNING FOR A LOW NON-ZERO FORCE, AND AN UNIDENTIFIED "FORCE LOW". THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ¿LOSS OF PRIME¿ WARNINGS OR DUPLICATED ALARMS. THE FORCE SENSOR WAS FOUND TO BE CALIBRATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE WITH THE PUMP. 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
    467196 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR