BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1896770 · Received November 10, 2010

    Report

    Report Number
    2939301-2010-09782
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 21, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN THREE TO FOUR DAYS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "92, 169, 172, 143 MG/DL" WITH THE SUBJECT METER; HOWEVER, DATES/TIMES OF THE READINGS ARE NOT KNOWN. THE PATIENT ALSO REPORTED ON (B)(6) 2010, HE OBTAINED A BLOOD GLUCOSE RESULT OF "39MG/DL" WITH THE EMERGENCY MEDICAL SERVICES" (EMS) METER (AT 5:30PM) AND ACCORDING TO THE CSR'S DOCUMENTATION, THE COMPARISON (BETWEEN THE SUBJECT METER AND EMS'S METER) WAS PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN HOW OFTEN THE PATIENT TESTS HIS BLOOD GLUCOSE; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DENIED TAKING ANY ACTION IN REGARDS TO HIS DIABETES MANAGEMENT. APPROXIMATELY 10-15 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED HE EXPERIENCED LOW BLOOD SUGAR; HOWEVER, PATIENT'S SPECIFIC SYMPTOMS ARE NOT KNOWN. ACCORDING TO THE CSR'S DOCUMENTATION, ON (B)(6) 2010, EMS WAS CONTACTED AND A HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED A RED SYRUP AS TREATMENT AT APPROXIMATELY 5PM. DURING TROUBLESHOOTING, THE CSR DISCOVERED THE PATIENT WAS NOT STORING THE TEST STRIPS CORRECTLY (AS RECOMMENDED BY THE OWNER'S MANUAL). HOWEVER, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, HE WAS CLEANING THE PUNCTURE AREA PROPERLY, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2984892

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R