BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1211564 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02743
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT THE ONETOUCH ULTRASMART METER IS GIVING INACCURATE HIGH READINGS. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE AND THE FOLLOW-UP ANSWERS OBTAINED ON OCTOBER 16, 2008. ON THE PREVIOUS MONTH AT APPROXIMATELY 2PM, THE PATIENT REPORTEDLY OBTAINED AN ELEVATED READING OF "19.4 MMOL/L" ON THE SUBJECT METER. PER THE LFS METER READING, THE PATIENT INCREASED HER NOVORAPID INSULIN TO 10 UNITS. AT 2:20PM, THE PATIENT REPORTEDLY WAS FEELING SICK AND OBTAINED A BLOOD GLUCOSE READING OF "1.9 MMOL/L." AT 5PM, THE PATIENT DROVE HERSELF TO THE HOSPITAL WHERE SHE WAS TREATED WITH ORAL GLUCOSE. THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "7.3 MMOL/L" ON THE ER/HOSPITAL METER AND WAS DIAGNOSED WITH "LOW BLOOD GLUCOSE" AT THE TIME OF CONCERN. THE PATIENT INDICATED THAT THERE HAD BEEN NO CHANGES IN HER DIET OR FOOD INTAKE PRIOR TO THE MEDICAL INTERVENTION. IN ADDITION, THE PATIENT CLAIMED SHE HAD FLU-LIKE SYMPTOM ON THE DAY OF CONCERN. THE AFOREMENTIONED SYMPTOMS LASTED THE WHOLE DAY. THE PATIENT FELT THAT HAD THE SUBJECT METER GIVEN ACCURATE READINGS AT 2PM, SHE WOULD HAVE TAKEN LESS INSULIN AND WOULD HAVE PREVENTED THE LOW BLOOD GLUCOSE EPISODE. PRIOR TO THIS EVENT, THE PATIENT TOOK HER RAPID INSULIN AS PER A SLIDING SCALE BASED ON HER BLOOD GLUCOSE RESULTS. AFTER THE INCIDENT, HER REGIMEN WAS CHANGED TO BE BASED ON CARB. COUNT ONLY. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, THE METER WAS CODED CORRECTLY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE EXPERIENCED HYPOGLYCEMIA AND WAS TREATED AT THE HOSPITAL AFTER SHE DOSED HER INSULIN PER AN ELEVATED LFS METER READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2841098

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R