BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242370 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11678
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE AUDIO BOLUS BUTTON COVER WAS MISSING FROM THE PUMP. THE BUTTON¿S RESPONSIVENESS COULD NOT BE TESTED. DURING TESTING, THE OK KEYPAD BUTTON WAS UNRESPONSIVE; ALL OTHER KEYPAD BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER ALL BUTTON CONTACTS AND AN UNRESPONSIVE OK KEYPAD BUTTON. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342527 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR