BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1030027 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00558
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM, AND IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING AN APPLY SAMPLE MESSAGE ON HER ONE TOUCH ULTRA 2 METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER, SINCE MAS WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PT. ON THE DAY BEFORE AROUND 2:00 AM, THE PT ATTEMPTED TO TEST AND OBTAINED AN APPLY SAMPLE MESSAGE. AFTER THE ISSUE BEGAN, SHE BEGAN TO FEEL SHAKY, SWEATY, AND ANXIOUS. SHE TREATED HERSELF WITH FOOD AND DID NOT SEEK ANY FURTHER MEDICAL TREATMENT. THE PT WAS NOT TESTED ON ANOTHER DEVICE. THE TECHNIQUE WAS DONE CORRECTLY AND THE PT RETESTED USING A NEW VIAL OF STRIPS, AND THE ISSUE WAS NOT RESOLVED. THE METER IS NOT A NEW PRODUCT. NO FURTHER CLINICAL INFO WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIABETES REGIMEN, READINGS PRIOR TO THE EVENT AND WHETHER THE PT FELT BETTER AFTER SELF-TREATMENT. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THAT SHE WAS UNABLE TO TEST DUE TO THE REPORTED ISSUE AND DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2799829

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| R