BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243790 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03208
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HER ONETOUCH ULTRA METER WAS DISPLAYING AN UNSPECIFIED ERROR MESSAGE AND THAT HER ONETOUCH ULTRA TEST STRIPS WERE TOO THICK TO BE INSERTED INTO THE METER. SHE CLAIMED THAT ABOUT 4-5 OUT OF 25 TEST STRIPS WERE EITHER TOO THICK OR WAS GIVING HER ERROR MESSAGES. IT IS UNKNOWN WHEN THE ERROR MESSAGE FIRST OCCURRED AND WHEN SHE FIRST NOTICED THE THICK TEST STRIPS. AT 10PM THREE DAYS PRIOR, THE PATIENT WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE LEVELS, BUT WAS GETTING ERROR MESSAGES. SHE REPORTEDLY RETESTED AND WAS ABLE TO GET AN UNSPECIFIED RESULT. BEFORE GOING TO BED THAT NIGHT, SHE TOOK 50 UNITS OF LEVEMIR AND 6 UNITS OF NOVOLOG. IT IS UNKNOWN IF THE PATIENT ADJUSTS HER INSULIN DOSAGES BASED ON THE METER READINGS. APPROXIMATELY 4.5 HOURS AFTER TAKING THE INSULIN, SHE REPORTEDLY "CRASHED." SHE INDICATED THAT SHE WAS DIZZY, DIZZY, SWEATY, AND HER EARS WERE PLUGGED UP. SHE CLAIMED THAT SHE BARELY MADE IT DOWNSTAIRS TO GET JUICE. SHE FELT THAT SHE MAY HAVE TAKEN TOO MUCH INSULIN BEFORE GOING TO BED AND THAT ONE OF HER METER READINGS WAS "FALSE". NO OTHER FORMS OF TREATMENT WERE REPORTED. BECAUSE THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PATIENT FOR MORE INFORMATION, THIS COMPLAINT IS BEING CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE RECORDED CALL AND THE CCA'S DOCUMENTATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT BECAME HYPOGLYCEMIC AFTER ALLEGEDLY TAKING TOO MUCH INSULIN. IN ADDITION, THE REPORTED TEST STRIPS WERE TOO THICK TO BE INSERTED INTO THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2761586

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R