BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093313 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26408
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 4, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 11/03/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN DID NOT DISPLAY A FLASHING-CONDITION DURING THE ANALYSIS: THE REPORTED ISSUE WAS NOT DUPLICATED. THE PUMP FAILED A LEAK TEST DUE TO A DISPLAY LENS LEAK; THE RELATION OF THIS DEVICE FAILURE TO THE REPORTED ISSUE CAN NOT BE DETERMINED, AS THE REPORTED ISSUE WOULD HAVE TO BE DUPLICATED TO DETERMINE SUCH. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF MOISTURE INGRESS WAS FOUND. UNRELATED TO THE REPORTED ISSUE, THE DISPLAY SCREEN VISUAL WAS OBSERVED TO BE DIM AND DISCOLORED DUE TO AN UNIDENTIFIED DISPLAY FAILURE. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (FLASHING DISPLAY W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN WAS FLASHING AND MOISTURE INGRESS WAS EVIDENT BEHIND THE DISPLAY LENS. REPORTEDLY, THE USER COULD NOT READ THE DISPLAY SCREEN SAFELY. 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
    571183 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR