BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3212269 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19172
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 1, 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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ¿INSTRUCTIONS FOR BLOOD GLUCOSE TESTING AFTER RESETTING THE METER WAS NOT CLEARLY PRESENT¿ IN HER ONETOUCH ULTRA2 METER OWNER¿S BOOKLET. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013 AFTER DINNER, AT APPROXIMATELY 6PM THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED TAKING A COMBINATION OF NOVOLOG ON A SLIDING SCALE BEFORE AND AFTER MEALS AND LANTUS, 30 UNITS IN THE MORNING AND AT BEDTIME. THE PATIENT REPORTED ON (B)(6) 2013 AFTER DINNER, SHE SKIPPED HER USUAL DOSE OF NOVOLOG INSULIN. THE PATIENT REPORTED A COUPLE OF HOURS LATER, SHE DEVELOPED SYMPTOMS OF ¿HOT, SWEATY, CLAMMY.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO RESOLVED THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314086 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening