BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3519810 · Received December 13, 2013

    Report

    Report Number
    2531779-2013-24236
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2013 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE TORN OVER THE OK BUTTON. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS WERE RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED KEYPAD, DISPLAY AND BATTERY COMPARTMENT ISSUES. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/02/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655171 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR