BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1211556 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02745
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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/PATIENT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING THAT THE ONE TOUCH ULTRAMINI METER WOULD NOT TURN ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CORRESPOND WITH THE PATIENT BY TELEPHONE ON OCTOBER 20, 2008 AND CLASSIFIED THE COMPLAINT BASED ON THE FOLLOWING INFORMATION RECEIVED FROM THE CUSTOMER. THE PATIENT TESTS HER BLOOD GLUCOSE ONCE A DAY AND SHE MANAGES HER DIABETES VIA GLYBURIDE TWICE DAILY. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN IN THE FIRST OR SECOND WEEK OF APPROX THREE MONTHS EARLIER (DATE AND TIME NOT SPECIFIED). DURING THAT TIME, THE SUBJECT METER STOPPED WORKING AND THE PATIENT REPORTEDLY THREW THE METER AWAY. FOLLOWING THE REPORTED ISSUE, SHE DID NOT MAKE ANY CHANGES TO HER DIABETIC MEDICATIONS, BUT STATED THAT SHE CONTROLLED HER DIET MORE STRICTLY AND SOMETIMES SKIPPED HER MEALS. ON AN UNKNOWN DAY IN THE MORNING, 2 TO 3 DAYS AFTER THE SUBJECT METER STOPPED WORKING, SHE REPORTEDLY EXPERIENCED "SWEATING" AND "FELT LIKE PASSING OUT." DURING HER SYMPTOMS, SHE REPORTEDLY OBTAINED A READING OF "50 MG/DL" ON HER MOTHER'S ONE TOUCH ULTRA METER. SHE REPORTEDLY DRANK ORANGE JUICE WITH SUGAR AND FELT BETTER WITHIN 10 MINUTES. SHE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT'S PRODUCTS WERE REPLACED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA, AFTER THE SUBJECT METE REPORTEDLY STOPPED WORKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening