BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1221858 · Received November 3, 2008

    Report

    Report Number
    2939301-2008-02918
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HIS ONE TOUCH ULTRA2 METER DOES NOT POWER ON USING THE TEST STRIPS. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: AFTER THE MORNING READING ON THREE DAYS EARLIER OF 149 MG/DL, THE PATIENT'S METER ALLEGEDLY STOPPED WORKING. THE METER WOULD NOT POWER ON WHEN A TEST STRIP WAS INSERTED INTO THE METER. THE PATIENT CONTINUED TO TAKE HIS DIABETES MEDICATION, EVEN THOUGH, THE METER STOPPED WORKING. THE PATIENT ATTEMPTED TO TEST ON HIS METER AT 11:55 AM ON THE DAY PRIOR TO ORIGINAL DATE, AND THE METER DID NOT POWER ON. THE PATIENT TOOK HIS NORMAL DOSAGE OF DIABETES MEDICATION. AT AROUND 6:30 PM (PRIOR TO DINNER), THE PATIENT WAS REPORTEDLY TREMBLING, SWEATING AND FELT FAINT. THE PATIENT DID NOT ATTEMPT TO TEST HIS BLOOD GLUCOSE. HE CONTACTED HIS PHYSICIAN WHO ADVISED HIM TO DO A DIPSTICK AND EAT. THE PATIENT USED A DIPSTICK AND OBTAINED A RESULT THAT WAS "NORMAL" AND THEN DRANK COKE AND ATE 2 PIECES OF BREAD. THE PATIENT FELT BETTER AN HOUR LATER AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. THE METER POWERS ON BY PRESSING THE POWER BUTTON; HOWEVER, DID NOT POWER ON WHEN INSERTING THE TEST STRIP INTO THE METER. THE PATIENT WAS USING THE CORRECT VIAL OF TEST STRIPS. THE PATIENT HAS HAD THE METER SINCE THREE MONTHS PRIOR TO ORIGINAL MONTH. A NORMAL READING IS BETWEEN 80-100 MG/DL. METER AND TEST STRIPS WERE REPLACED. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY REPORTED THAT HIS METER WOULD NOT POWER ON FOR THREE DAYS AND REPORTED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA ON THE THIRD DAY. THE PATIENT FELT BETTER AFTER SELF-TREATMENT AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2863907

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R