BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1222086 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02933
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    June 30, 1905
    Report Date
    October 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN/VERIFY ADDITIONAL INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE AT LEAST FOUR TIMES A DAY: 5:45 AM, NOON, AROUND 6 PM, AND BEFORE GOING TO BED AT NIGHT. HE ALSO MANAGES HIS DIABETES WITH SLIDING SCALE INSULIN (THAT IS USUALLY TAKEN BASED ON METER READINGS) AND PILLS. THE PATIENT STATED THAT FOR ABOUT 5-6 MONTHS, HIS METER HAS BEEN READING "HIGHER" THAN NORMAL. AS A RESULT, THE PATIENT CLAIMED THAT HE DID NOT MAKE ANY CHANGES TO HIS DIABETES MANAGEMENT. A FEW WEEKS AGO, THE PATIENT "BELIEVED" THAT HIS METER COULD BE READING HIGHER THAN NORMAL DUE TO A "NORMAL" LAB RESULT (UNKNOWN READING) OBTAINED FROM THE HEALTHCARE PROFESSIONAL. THE PATIENT'S HCP DID NOT PROVIDE ANY TREATMENT AT THE TIME, HIS ONLY ADVICE WAS TO HAVE THE PATIENT CONTINUE WITH HIS NORMAL ROUTINE TO MANAGE HIS DIABETES; NO OTHER TREATMENTS WERE ADMINISTERED WHILE IN HIS OFFICE. AT AN UNKNOWN TIME AFTER THE METER ISSUE, THE PATIENT CLAIMED THAT HE "SOMETIMES" WOULD WAKE UP IN THE MIDDLE OF THE NIGHT FEELING SWEATY BUT REPORTEDLY DID NOT SELF-TREAT OR TESTED HIS BLOOD GLUCOSE. WHEN THE PATIENT AWAKES FROM HIS SLEEP (USUALLY 5:45AM), HIS BLOOD GLUCOSE WOULD BE IN THE "200'S MG/DL", WHICH WAS REPORTEDLY "STRANGE" FOR HIM. THE PATIENT CLAIMED THAT HE FELT "NORMAL" AT THE HIGHER READINGS AND CONTINUED WITH HIS DAILY ROUTINE (PER HCP) TO MANAGE HIS DIABETES. HE REPORTEDLY CONTINUED TAKING HIS HUMALOG BASED ON THE METER READINGS. THE TESTING TECHNIQUE WAS CORRECT AND THE PUNCTURE SITE WAS CLEANED PROPERLY AT THE TIME OF TESTING. THE UNIT OF MEASUREMENT WAS SET CORRECTLY TO MG/DL. THE TEST STRIPS WERE IN GOOD CONDITION AND THE CODE MATCHES WITH THE CODE ON THE TEST STRIP VIAL. HOWEVER, THE PATIENT WAS USING TEST STRIPS THAT HAVE BEEN OPEN PAST THE DISCARD DATE. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. THERE IS INSUFFICIENT INFORMATION TO SUGGEST THAT THE METER MALFUNCTIONED BECAUSE COMPARING METER READINGS TO NORMAL READINGS OR FEELINGS IS AN ANECDOTAL COMPARISON. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2756180

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening