BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1911141 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10372
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 13, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HER BLOOD GLUCOSE EVERY OTHER DAY AND MANAGES HER DIABETES WITH (B)(6) (1 TABLET IN THE AFTERNOON BEFORE BREAKFAST) AND HUMAN MIXTARD (10 UNITS BEFORE BREAKFAST).THE ALLEGED ISSUE BEGAN ABOUT 4-5 MONTHS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS "ABOVE 300 MG/DL" WITH A LIFESCAN METER AND "LESS THAN 200 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10-15 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. THE PATIENT STATED SHE INCREASED HER USUAL DOSE OF INSULIN DUE TO THE HIGHER READINGS OBTAINED ON THE SUBJECT METER. IMMEDIATELY AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SWEATY AND GIDDY. THE PATIENT WAS GIVEN SUGAR WATER AND FELT BETTER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening