BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983548 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22561
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/09/2014 WITH THE FOLLOWING FINDINGS: A CARTRIDGE CAP AND BATTERY CAP WERE NOT RETURNED WITH THE DEVICE; A TEST BATTERY CAP WAS USED DURING ALL STEPS OF THE ANALYSIS. THE PUMP POWERED ON, BUT THE DISPLAY SCREEN WAS BLANK; THE REPORTED EVENT WAS DUPLICATED. THE PUMP CASE WAS REMOVED, AND THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. THE SUSPECT DISPLAY SCREEN WAS REPLACED WITH A TEST DISPLAY SCREEN; THE PUMP DISPLAY FUNCTIONED PROPERLY WITH THE TEST DISPLAY SCREEN INSTALLED, SUGGESTING THE DISPLAY SCREEN DAMAGE WAS THE CAUSE OF THE BLANK DISPLAY.

    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 (BLANK SCREEN) ISSUE. 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
    461798 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR