BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3935627 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20129
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED; THE REPORTED EVENT WAS DUPLICATED. UNRELATED TO THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE GRIP PAD. ALSO UNRELATED TO THE REPORTED EVENT, THE DISPLAY LENS WAS FOUND TO BE CRACKED ALONG THE TOP AND BOTTOM OF ITS PERIMETER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE REPORTER ALLEGED THAT THE DISPLAY SCREEN WAS DIM AND COULD BE READ SAFELY. IT WAS ALSO REPORTED THAT THERE WAS NO EVIDENCE OF MOISTURE IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    412773 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR