BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811533 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13586
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 PRIME ISSUE. THE REPORTER STATED THAT THE PUMP HAD EXPERIENCED A LOSS OF PRIME WARNING WITH TWO DIFFERENT BATTERY CAPS DURING THE LOAD STEP. THE REPORTER STATED THAT THE CARTRIDGE CAP HAD BEEN SECURED AND WHEN THE LOSS OF PRIME WARNINGS OCCURRED, THE CARTRIDGE CAP BECAME LOOSE. REPORTEDLY, THERE WAS NO VISIBLE DAMAGE TO THE BATTERY CAP OR CARTRIDGE COMPARTMENT OR THE CARTRIDGE COMPARTMENT THREADS. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290211 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR