BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243823 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03222
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 16, 2008
    Report Date
    November 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/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.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER HAD AN INACCURACY ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT TESTS HIS BLOOD SUGAR MORE THAN 4 TIMES A DAY. HE MANAGES HIS DIABETES VIA HUMALOG ON A SLIDING SCALE AND LANTUS 15 UNITS EVERY MORNING. THE PATIENT STATED THAT THE REPORTED ISSUE BEGAN ON THE SAME DAY IN THE EARLY MORNING. DURING THAT TIME, THE PATIENT REPORTEDLY OBTAINED INACCURATE READINGS OF "81MG/DL AND 289MG/DL" ON THE SUBJECT METER, PERFORMED IN A MINUTE APRT. BASED ON THE STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20MG/DL. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT REPORTEDLY TOOK INSULIN (UNKNOWN TYPE AND DOSES) BASED ON A SLIDING SCALE. APPROXIMATELY TWO AND HALF HOURS LATER, THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "LOW BLOOD SUGAR" AND "FELT LIKE PASSING OUT." IT IS NOT KNOWN WHETHER THE PATIENT TESTED HIS BLOOD SUGAR DURING HIS SYMPTOMS. HIS WIFE, THEN REPORTEDLY GAVE HIM A GLUCAGON INJECTION FOLLOWING THE SYMPTOMS. THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE. DURING THE TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS. THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND HE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA, AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2848731

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening