BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1930812 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10801
    Event Type
    Injury
    Date Received
    December 16, 2010
    Report Date
    November 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. A 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR FOLLOW UP QUESTIONS ON (B)(6) 2010 AND (B)(6) 2010; HOWEVER, THE MSS WAS NOT ABLE TO GET A HOLD OF THE PATIENT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY 2 WEEKS AGO PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "106, 136, AND 140 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS IS LESS THAN THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT INDICATED HE MANAGES HIS DIABETES WITH NOVOLOG INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE CONTINUED TO TAKE HIS USUAL INSULIN DOSE EVERY MORNING AND AFTERNOON. IT IS NOTED THAT THE PATIENT TAKES 21 UNITS AND 19 UNITS EVERY DAY; HOWEVER, IT IS NOT KNOWN WHICH AMOUNT HE TAKES IN THE MORNING AND AFTERNOON. THE PATIENT STATED HE DEVELOPED SYMPTOMS OF BLURRED VISION, SHAKY, AND A HEADACHE 12 DAYS AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF THE SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, AN APPROVED SAMPLE SITE WAS USED, AND THE CODE WAS NOT SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED THE SYMPTOMS AS HIGH OR LOW BLOOD SUGAR SYMPTOMS. THEREFORE, 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3023542

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening