BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 850591 · Received May 11, 2007

    Report

    Report Number
    2939301-2007-00359
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    April 27, 2007
    Report Date
    April 27, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    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 RESULT IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2007, THE LAY PT AND HER HUSBAND CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PT'S ONE TOUCH ULTRA SMART METER READ INACCURATELY HIGH. THE PATIENT SAID SHE OBTAINED A READING OF 130 MG/DL ON THE REPORTED METER ON THE MORNING OF THE SAME DAY. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S DIABETES TREATMENT REGIMEN, MEDICATIONS, OR ACTIONS TAKEN AFTER SHE OBTAINED THE 130 MG/DL READING. THE PATIENT WAS AT WORK WHEN SHE "STARTED FEELING A LITTLE FUNNY." SHE TESTED WITH THE REPORTED METER AND OBTAINED A RESULT OF 155 MG/DL. ABOUT 20 MINUTES LATER, THE PATIENT WAS DISORIENTED. PERSONNEL AT HER WORK CALLED EMS. EMT'S OBTAINED A RESULT OF 40 MG/DL ON THE EMS METER AT ABOUT 12:00PM. THE EMT'S TREATED THE PATIENT WITH A TUBE OF ORAL GLUCOSE. THE PATIENT WENT TO SEE HER DOCTOR AFTER RECEIVING THE EMS TREATMENT. NO INFORMATION WAS PROVIDED REGARDING READINGS OR OTHER TREATMENT RECEIVED AT THE DOCTOR'S OFFICE. THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE TEST STRIPS AND VIAL WERE IN GOOD CONDITION. THE TEST STRIPS WERE NOT EXPIRED, HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, AND HAD BEEN STORED CORRECTLY. THE CODE ON THE METER MATCHED THE TEST STRIP CODE. THE CCA CONFIRMED THAT THE PATIENT FOLLOWED CORRECT TESTING TECHNIQUE. THE CCA WALKED THE PATIENT THROUGH PERFORMING TWO CONTROL SOLUTION TESTS. THE CONTROL SOLUTION RESULT 130 AND 121 MG/DL WERE WITHIN SPECIFICATIONS (108-144 MG/DL) THOUGH THE PATIENT'S HUSBAND INDICATED THE CONTROL SOLUTION EXPIRATION DATE WAS 11/2006. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT ALLEGES THE LFS PRODUCT READ INACCURATELY HIGH COMPARED TO THE PATIENT'S SYMPTOMS THE SUGGESTED HYPOGLYCEMIA AND TO A HYPOGLYCEMIC READING ON THE EMS DEVICE. THE PATIENT CLAIMS SHE WAS TREATED WITH ORAL GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2677535

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R