BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2983622 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03950
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS DISPLAYING HER PAST METER READINGS WHEN ATTEMPTING TO TEST HER BLOOD GLUCOSE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE STARTED ON (B)(6) 2013 AT 8:15AM. IT WAS NOTED THAT THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION(S). THE PATIENT DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMENT DUE TO THE METER ISSUE. THE PATIENT ALSO DENIED DEVELOPING SYMPTOMS; HOWEVER, REPORTED THAT LATER THAT DAY SHE WENT TO THE ER AND WAS TREATED WITH INSULIN. THE PATIENT STATED HER BLOOD GLUCOSE WAS UP TO "404 MG/DL" WHEN TESTED ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE ALLEGED METER ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT WAS REPORTEDLY TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87499 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3378882

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R