BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5183516 · Received October 28, 2015

    Report

    Report Number
    2531779-2015-38931
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Report Date
    October 15, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 TESTING, THE OK KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THE OK KEY CONTACT WAS FOUND TO BE INVERTED. EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE OK BUTTON CONTACT. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED ON THE LEFT SIDE. ADDITIONALLY, THE KEYPAD COVER WAS MISSING FROM THE PUMP. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A KEYPAD BUTTON RESPONSE ISSUE WITH A BUTTON CONTACT DEFECT AND EVIDENCE OF CONTAMINATION. ADDITIONALLY, THE BATTERY COMPARTMENT WAS FOUND TO BE DAMAGED. 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
    712919 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR