BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4852963 · Received June 18, 2015

    Report

    Report Number
    2531779-2015-20227
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL OF THE KEYPAD BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD WAS PEELING FROM THE BOTTOM OF THE KEYPAD TO THE OK BUTTON. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS EVIDENCE OF CONTAMINATION UNDER ALL OF THE KEYPAD BUTTON CONTACTS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396745 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR