BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081824 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01483
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    ON JULY 14, 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT TESTS HER BLOOD SUGAR AT LEAST FOUR TIMES A DAY AND TAKES AN UNSPECIFIED TYPE OF INSULIN ON A SLIDING SCALE TO MANAGE HER DIABETES. ON AN UNSPECIFIED DATE, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "275 MG/DL" WITH A LFS METER AND A "150 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN T HE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY INCREASED HER INSULIN INTAKE (UNSPECIFIED AMOUNT) BASED ON THE METER RESULTS. SOMETIME AFTER THE ALLEGED METER ISSUE AND AFTER TAKING THE EXTRA INSULIN, THE PATIENT REPORTEDLY FELT SYMPTOMS OF "SHAKY, SWEATY AND BOTTOMED-OUT". IT WAS NOT MENTIONED WHETHER THE PATIENT SOUGHT ANY MEDICAL INTERVENTIONS OR TREATED HERSELF AS A RESULT OF THE REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND CLEANED THE PUNCTURE SITE PROPERLY. THE CORRECT UNIT OF MEASURE WAS SET: MG/DL. THE CODE ON THE TEST STRIP VIAL MATCHES WITH THE CODE ON THE METER. THE METER WAS NOT DAMAGED IN ANY WAY. WHEN A CONTROL SOLUTION TEST WAS PERFORMED, THE CONTROL SOLUTION RESULT FELL OUT OF THE SPECIFIED RANGE. HOWEVER, WHEN A RETEST WAS PERFORMED WITH A NEW VIAL OF TEST STRIP, THE RESULT FELL WITHIN RANGE; THEREFORE, INDICATING A STRIP ISSUE WITH THE REPORTED TEST STRIP VIAL. THE TEST STRIPS WERE IN GOOD CONDITION. THE PATIENT'S PRODUCTS ARE BEING REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT CLAIMED THAT SHE OBTAINED AN ALLEGEDLY INACCURATE HIGH READING ON THE SUBJECT METER AND REPORTEDLY TOOK EXTRA INSULIN. SHE ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2743438

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening