BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3925128 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19507
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/02/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. ON INVESTIGATION, THE PUMP POWERED UP TO A DIM AND DISCOLORED VERIFY SCREEN. THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE CAP AND CASE SEAL. THE KEYPAD COVER WAS TORN BUT ALL THE BUTTONS RESPONDED PROPERLY. REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER ALL THE BUTTON CONTACTS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE DISPLAY WAS DIM/DISCOLORED, THE BATTERY COMPARTMENT WAS CRACKED, AND THERE WAS CONTAMINATION UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 07/02/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404324 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR