BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1930815 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10803
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 22, 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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR A FOLLOW UP CALL ON (B)(6) 2010; HOWEVER THE PATIENT STATED SHE WAS NOT AVAILABLE AND THAT SHE WAS LEAVING TOWN AND DOES NOT KNOW WHEN SHE WILL BE BACK. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 (UNSPECIFIED TIME). THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "435 AND 325 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). ON (B)(6) 2010 AT 3:00AM, THE PATIENT CLAIMED SHE CONTINUED HER USUAL DOSE OF 20 UNITS OF INSULIN (TYPE UNKNOWN), AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED ON (B)(6) 2010, THE PATIENT BECAME SHAKY AND SWEATY. THE PATIENT HOWEVER 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 HER PROCESS FOR TESTING WAS CORRECT. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION, IT IS NOT KNOWN WHETHER THE SYMPTOMS WERE ASSOCIATED 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3004721

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening