BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233001 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11236
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 08/20/2013, DEVICE EVALUATION: ON TESTING, THE PUMP POWERED ON WITH A FULLY FUNCTIONAL, LEGIBLE DISPLAY. INVESTIGATION WAS UNABLE TO CONFIRM OR DUPLICATE THE DISPLAY COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS TO REPORT THE INSULIN PUMP DISPLAY SCREEN WAS DIM/FADING. THERE WAS NO REPORTED DAMAGE TO THE PUMP CASING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332978 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR