BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3872717 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-17020
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. EVALUATION ALSO REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE KEYPAD WAS FOUND TO BE TORN FROM THE DOWN ARROW SYMBOL THROUGH THE UP ARROW SYMBOL. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDERNEATH ALL OF THE BUTTON CONTACTS. UNRELATED TO THESE ISSUES, THE LABEL ON THE PUMP WAS FOUND TO BE PEELING, DAMAGED, AND ILLEGIBLE AND THE CONTRAST BUTTON WAS FOUND TO BE NON-RESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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 THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE DISPLAY SCREEN WAS DIM AND DISCOLORED. EVALUATION ALSO REVEALED EVIDENCE OF CONTAMINATION UNDERNEATH ALL OF THE BUTTON CONTACTS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349597 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR