BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4243350 · Received November 11, 2014

    Report

    Report Number
    2531779-2014-32185
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 11/3/2014 WITH THE FOLLOWING FINDINGS: DISPLAY IS DIM/FADING/REDDISH, BATTERY COMPARTMENT IS CRACKED BELOW BUMPER PAD, INVESTIGATION COMPLETED USING THE RETURNED BATTERY CAP, BATTERY CAP IS DAMAGED/STRIPPED. PUMP CASE WAS REMOVED AND CORROSION WAS FOUND UNDERNEATH THE INTERNAL BATTERY. BLACK BOX CONFIRMED TIME AND DATE RESET TO DEFAULT AFTER BATTERY CHANGE ON 09/09/2014, PUMP WAS EXERCISE FOR 24 HOURS, THEN TOOK OUT THE BATTERY FOR 6 HOURS AND THE TIME AND DATE RESET COMPLAINT WAS DUPLICATED ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A DIM DISPLAY, DAMAGED BATTERY COMPARTMENT AND CAP. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 11/3/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726050 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR