BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1289479 · Received January 13, 2009

    Report

    Report Number
    2939301-2009-00198
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    January 4, 2009
    Report Date
    January 6, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 2009, THE LAY USER/PATIENT IN ANOTHER COUNTRY, CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. ON THE MORNING OF THE EVENT DATE, BEFORE BREAKFAST, THE PATIENT PERFORMED BLOOD GLUCOSE TESTS AND REPORTEDLY OBTAINED RESULTS OF 306 AND 334 MG/DL. SHE DECIDED TO TAKE 6 UNITS OF RAPID-ACTING INSULIN AND 9 UNITS OF LANTUS BASED ON THE RESULT. THE PATIENT TAKES HER INSULIN ON A SLIDING SCALE. BEFORE LUNCH, THE PATIENT OBTAINED A RESULT OF 117 MG/DL AND TOOK 4.5 UNITS OF THE RAPID INSULIN. AT 1PM, THE PATIENT REPORTEDLY FELT WEAK AND FELL UNCONSCIOUS. SHE FELL AND COULDN'T TEST. SHE STATED SHE STAYED UNCONSCIOUS FOR AROUND 5 HOURS. THE PATIENT CAME BACK TO HER SENSES WITHOUT ANY OUTSIDE HELP, HAD ORAL SUGAR AND FELT BETTER AT 7:30PM. SHE TESTED HER BLOOD SUGAR AT THAT TIME AND OBTAINED A RESULT OF 172 MG/DL. THE PATIENT TESTS HER BLOOD SUGAR 4 TIMES PER DAY AND MORE WHEN SHE FEELS WORRIED ABOUT HER BLOOD SUGAR. THE PATIENT ALSO CLAIMS THAT SHE HAS HAD RESULTS AROUND 430 MG/DL IN THE EVENING IN THE SAME MONTH. THE PATIENT'S TARGET BLOOD GLUCOSE LEVEL IS 130 MG/DL. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE PUNCTURE AREA WAS CLEANED CORRECTLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AT THE TIME OF TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED SHE OBTAINED INACCURATELY HIGH RESULTS, TOOK ADDITIONAL INSULIN BASED ON THE RESULTS, AND FELL UNCONSCIOUS DUE TO HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2867107

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R