BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3063026 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04406
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED AND DISCOLORED. THE DIM/FADED DISPLAY WAS REPLACED WITH A TEST DISPLAY; THE TEST SCREEN WAS FOUND TO HAVE NORMAL CONTRAST. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD WAS FOUND TO BE PEELING OFF FROM THE BASE. ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL BUTTON KEY CONTACTS. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/FADED AND DISCOLORED DISPLAY SCREEN. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166099 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR