BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2940777 · Received December 8, 2006

    Report

    Report Number
    2939301-2006-01707
    Event Type
    Injury
    Date Received
    December 8, 2006
    Date of Event
    August 20, 2006
    Report Date
    August 21, 2006
    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 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. DEVICE ID#: (B)(4) OT ULTRA METER.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE LAY-USER/PATIENT CONTACTED LIFESCAN (B)(6) ALLEGING THAT HIS ONE TOUCH ULTRA METER WAS INCORRECTLY SET TO "MG/DL." THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CORRESPONDED WITH THE PATIENT ON (B)(6) 2006, TO OBTAIN/VERIFY INFORMATION. THE PATIENT INDICATED THAT HE STARTED SEEING HIS METER RESULTS SET TO "MMOL/L" ON (B)(6) 2006. AFTER CHANGING THE METER'S BATTERY ON (B)(6) 2006, THE PATIENT STARTED NOTICING THAT HE WAS GETTING HIGH RESULTS SUCH AS "121, 131, AND 141 MG/DL." AS A RESULT OF GETTING THE HIGH RESULTS, THE PATIENT STARTED TAKING AN EXTRA 1/2 PILL OF "GLYBURIDE" IN THE MORNING AND EVENING. HIS PRESCRIBED DAILY DOSE AT THE TIME WAS 1/2 PILL OF "GLYBURIDE" (5 MG) ONCE A DAY AND "METFORMIN" (500 MG) THREE TIMES/DAY. ON (B)(6) 2006, THE PATIENT OBTAINED A RESULT OF "91 MG/DL" THAT HE INTERPRETED AS "9.1 MMOL/L." AT THE TIME, HE HAD SYMPTOMS OF FEELING FAINT SO HE CALLED A NURSE. THE NURSE ADVISED HIM TO STOP USING THE METER. THE PATIENT ADMINISTERED SELF-CARE BY EATING TOAST WITH JAM. HE FELT BETTER AFTERWARDS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT'S METER WAS INCORRECTLY SET TO "MG/DL." HE PERCEIVED HIS RESULTS AS BEING HIGH. THE PATIENT INCREASED HIS MEDICATION REGIMEN AND DEVELOPED SYMPTOMS OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2636249

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening