BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4232280 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31751
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/21/2014 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. THE OK KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE TO USER PRESSES; ALL OTHER KEYPAD BUTTONS FUNCTIONED PROPERLY. THE KEYPAD COVER WAS REMOVED, AND CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT, A DIM AND DISCOLORED DISPLAY, A KEYPAD BUTTON RESPONSE ISSUE, AND CONTAMINATION UNDER KEYPAD BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/21/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712773 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36