BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3193391 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09143
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ON EXAMINATION, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED FROM THE THREADS TO THE PUMP CASE SEAL. THE THREADS ON THE INSIDE OF THE BATTERY COMPARTMENT WERE NOTED TO BE STRIPPED. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION HAD STRIPPED THREADS. WHEN ATTACHED TO THE PUMP, THE YELLOW O-RING ON THE BATTERY CAP WAS VISIBLE AND THE CAP WOULD NOT SECURE PROPERLY ONTO THE PUMP. THE BATTERY CAP WAS MEASURED AND NOTED TO BE OUT OF SPECIFICATIONS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013: THE BATTERY CAP WAS DAMAGED AND MEASUREMENTS WERE OUT OF SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292188 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR