BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 902435 · Received August 22, 2007

    Report

    Report Number
    2939301-2007-00781
    Event Type
    Injury
    Date Received
    August 22, 2007
    Date of Event
    July 28, 2007
    Report Date
    July 29, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 THE FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 29, 2007, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING, THE ONE TOUCH ULTRA2 METER IS GIVING INACCURATE HIGH READINGS. IN 2007, AT 10 PM (CST), THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "244, 325, 251, AND 244 MG/DL (CCA'S VERIFIED ACTUAL READINGS IN THE METER AS 242, 251, 325, 211, 90 MG/DL)" WITH A LIFESCAN METER AND "90 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <=30MG/DL. ON THAT DAY, THE PATIENT TOOK HER USUAL DOSE OF BOLUS INSULIN MEDICATION (50 UNITS OF 70/30 NOVALOG) AFTER OBTAINING THE METER READINGS. THE PATIENT WAS REPORTED TO HAVE SYMPTOM OF "SWEATY" SOMETIME AFTER TAKING HER USUAL DOSE OF DIABETES MEDICATION. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION BECAUSE OF THE REPORTED ISSUE. DURING THE TROUBLESHOOTING SESSION, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THAT THE METER WAS CODED CORRECTLY, THE PUNCTURED AREA WAS CLEANED PROPERLY, THE UNIT OF MEASUREMENT WAS CORREECTLY SET, THE TEST STRIP WAS IN GOOD CONDITION, THE TEST STRIP WAS IN GOOD CONDITION, THE TEST STRIP VIAL WAS IN GOOD CONDITION, AND THE CONTROL SOLUTION TEST HAD PASSED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED SHE BECAME TOO SWEATY AND OBTAINING HIGH RESULTS AND TAKING HER USUAL DOSE OF INSULIN. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2664154

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening