BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1020930 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00397
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO 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 ALLEGING THAT A ONE TOUCH ULTRASMART METER HAD READ INACCURATELY HIGH. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON A DAY EARLIER, AT 12:50 PM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "220 MG/DL AND UP." AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT TOOK AN INCREASED DOSE OF DIABETES MEDICATION. THE PATIENT TOOK 72 UNITS OF LANTUS INSULIN BEFORE TESTING AND 50 UNITS AFTER. IT IS NOT KNOWN WHAT TIMES THE METER READINGS WERE OBTAINED. IT IS ALSO UNCLEAR AS TO WHAT SPECIFIC TIMES THE INSULIN DOSAGES WERE TAKEN IN RELATION TO WHEN THE REPORTED METER RESULTS WERE OBTAINED. ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY AND LIGHTHEADED. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT DATE/TIME THE RESULT OF "220 MG/DL" WAS OBTAINED, WHAT DATES/TIMES THE INSULIN DOSAGES WERE TAKEN, WHAT DATE/TIME THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THIS MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PATIENT TO OBTAIN THIS INFORMATION. THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE STARTED. THE PATIENT HAD TAKEN INCREASED DOSAGE(S) OF INSULIN AS A RESULT OF THE ALLEGED INACCURATE HIGH METER RESULT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2740465

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening