BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241976 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11661
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ON INVESTIGATION, THE PUMP POWERED ON WITH A DIM, DISCOLORED DISPLAY. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY AND WAS CLEARLY LEGIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DIM AND FADING DISPLAY. THE DISPLAY HAS BECOME VERY DIM. THE ISSUE GRADUALLY OCCURRED BEGINNING EIGHT MONTHS PRIOR TO THE COMPLAINT. 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
    340407 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR