BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811520 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13561
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 6, 2014
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2014 WITH THE FOLLOWING FINDING:VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BELOW THE FINGER PAD. DURING TESTING, THE DISPLAY WAS FOUND TO BE DIM/FADING/DISCOLORED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD COVER WAS PEELING OF AT THE OK BUTTON. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY BUTTON CONTACTS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. INVESTIGATION ALSO REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/06/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292068 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR