BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 1993960 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01411
    Event Type
    Injury
    Date Received
    February 16, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH SELECT METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2010 (TIME NOT SPECIFIED). ON (B)(6) 2011(AT 8:35AM) THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF "16.6 AND 11.2 MMOL/L" WITH THE SUBJECT METER, PERFORMED WITHIN A MINUTE FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 1.11 MMOL/L. ALONG WITH DIET AND EXERCISE, THE PATIENT MANAGES THEIR DIABETES WITH TWO TABLETS OF METFORMIN (500MG EACH) AND TWO TABLETS OF GLYBURIDE (5MG EACH) PER DAY. ACCORDING TO THE CSR'S DOCUMENTATION, IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT CONTINUED WITH HER USUAL DOSE OF MEDICATION ON (B)(6) 2011 AT APPROXIMATELY 11AM. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF WEAKNESS, FEELING DROWSY, AND BLURRY VISION APPROXIMATELY EIGHT DAYS AFTER THE ALLEGED ISSUE BEGAN. DURING A DOCTOR'S OFFICE VISIT ON (B)(6) 2011 (TIME NOT SPECIFIED) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "10.5MM/L" WITH THE DOCTOR/CLINIC'S METER AND THE PATIENT'S PHYSICIAN INCREASED HER DIABETES ORAL MEDICATION TO FOUR TABLETS PER DAY. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MMOL/L), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3029137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening