BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4112349 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27262
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED FROM THE TOP. THE THREADS WERE STRIPPED INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP THREADS WERE STRIPPED. THE BATTERY CAP HAD A CONTACT HEIGHT DEFECT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BATTERY COMPARTMENT CRACK AND THE BATTERY CAP THREADS WERE DAMAGED. IT WAS REPORTED THE BATTERY CAP WAS NEVER CHANGED AND IN USE SINCE (B)(6) 2013; THE USER GUIDE INSTRUCTS THE BATTERY CAP BE CHANGED EVERY 3-6 MONTHS. 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
    592305 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR