BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3081446 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05389
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: TESTING CONFIRMED THE DISPLAY HAS A PERSISTENT HORIZONTAL LINE THROUGH THE LETTERING ON THE DISPLAY SCREEN. THE PUMP COVER WAS REMOVED TO INVESTIGATE. THE DISPLAY SCREEN HAS NO VISIBLE DAMAGE. THE DISPLAY SCREEN WAS RE-SEATED AND TESTED. THE PERSISTENT HORIZONTAL LINE WAS STILL PRESENT. A TEST SCREEN WAS INSERTED. THE TEST SCREEN FUNCTIONED PROPERLY WITH NO PERSISTENT LINES VISIBLE ON THE SCREEN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING) ISSUE. THE REPORTER STATED THERE ARE TWO BLUE LINES THROUGH THE MIDDLE OF THE DISPLAY. 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
    184921 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR