BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033278 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03493
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS FOUND TO BE DIM/FADED. A TEST SCREEN WAS INSERTED AND FUNCTIONED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE DISPLAY SCREEN WAS GRADUALLY BECOMING MORE DIM. THERE IS NO INDICATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE DISPLAY ISSUE WHICH WAS UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136627 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR