BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811534 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13588
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS AS FOLLOWS: THE TOP OF THE BATTERY CAP WAS OBSERVED TO BE STRIPPED. A TEST PUMP WAS USED TO COMPLETE THE INVESTIGATION. THE CAP WAS ABLE TO FULLY TIGHTEN UNTIL THE O-RING WAS SEATED AND THE CAP WAS FLUSH WITH THE PUMP CASE. NO POWER REBOOTS OCCURRED. PRODUCT ANALYSIS WAS UNABLE TO REMOVE THE CAP FROM THE PUMP NORMALLY AND USED PLIERS TO REMOVE THE BATTERY CAP. THE BATTERY CAP THREADS WERE OBSERVED TO BE INTACT AND THE BATTERY CAP SPRING WAS SECURE. THE BATTERY CAP HEIGHT AND WIDTH CONTACTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A CASING CONDITION ISSUE. THIS COMPLAINT IS AGAINST THE BATTERY CAP ALONE. THE REPORTER STATED THAT THE BATTERY CAP WAS WORN AND HAD BEEN CHANGED WITHIN THE LAST 1 TO 3 MONTHS. 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
    291847 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR