BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1020929 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00394
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    August 3, 2001
    Report Date
    March 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS INTERMITTENTLY FAILING CONTROL SOLUTION TESTS HIGH. THE PATIENT TESTS HER BLOOD GLUCOSE 3 TIMES A DAY. SHE TESTS 2 HOURS AFTER EACH MEAL. THE PATIENT TAKES METFORMIN EVERY MORNING AND EVENING TIME. SHE ALSO TAKES GLYBURIDE IN THE MORNING. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ABOUT 2 WEEKS AGO. DURING THAT TIME, THE PATIENT WAS UNABLE TO CONSISTENTLY TEST HER BLOOD GLUCOSE. THE PATIENT EXPLAINED THAT WHENEVER THE CONTROL SOLUTION TEST FAILED, SHE DID NOT TEST HER BLOOD GLUCOSE. WHENEVER THE CONTROL SOLUTION TEST PASSED, SHE IMMEDIATELY TESTED HER BLOOD GLUCOSE. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SICK, SHAKY, AND TIRED. THE PATIENT TESTED HER BLOOD GLUCOSE WHILE SHE HAD THE SYMPTOMS AND GOT A RESULT OF "3.3 MMOL/L." THE PATIENT ADMINISTERED SELF-CARE BY CONSUMING A TEASPOON OF RAW SUGAR AND EATING "BABY COOKIES." THE SELF-TREATMENT HELPED TO RELIEVE HER SYMPTOMS. THE PATIENT WAS NOT STORING HER CONTROL SOLUTION PROPERLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. SHE ATE FOOD TO RELIEVE HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2788378

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R