BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243815 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03219
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED THE 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, THA LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER WAS READING INACCURATELY. THE PT TESTS HER BLOOD GLUCOSE 5 TIMES A DAY. SHE TESTS BEFORE AND AFTER BREAKFAST, AND BEFORE LUNCH, DINNER, AND BEDTIME. THE PT TAKES SLIDING-SCALE HUMALOG INSULIN BASED ON HER METER READINGS. SHE ALSO TAKES SLIDING-SCALE LANTUS INSULIN BEFORE BEDTIME. THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED TOWARDS THREE MONTHS EARLIER. THE PT EXPLAINED THAT AT THAT TIME SHE WAS ON VACATION AND WAS ALWAYS GETTING LOW READINGS SUCH AS "64 AND 65 MG/DL". HOWEVER, WHEN THE PT ARRIVED HOME FROM VACATION AND VISITED HER DOCTOR, SHE CLAIMED THAT HER DOCTOR TOLD HER THAT HER HBA1C RESULT WAS HIGH. SHE WAS TOLD THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN HIGH. THE PT ALLEGED THAT THE METER WAS READING INACCURATELY LOW. IN ANOTHER INSTANCE, THE PT ALLEGED THAT THE METER WAS READING INACCURATELY LOW. IN ANOTHER INSTANCE, THE PT ALLEGED THAT THE METER WAS READING INACCURATELY HIGH. ON AN UNSPECIFIED DATE, THE PT CLAIMED THAT SHE TOOK TOO MUCH SLIDING-SCALE HUMALOG INSULIN BASED ON AN INACCURATE HIGH PRE-BREAKFAST METER READING. THE PT WAS UNABLE TO RECALL WHAT ACTUAL READING WAS OBTAINED. HOWEVER, ABOUT 5 MINS AFTER TAKING THE INSULIN, THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SWEATING AND FELT LOW. THE PT IMMEDIATELY TESTED HER BLOOD GLUCOSE AFTER FEELING SWEATY AND GOT A RESULT OF "44 MG/DL." THE PT ADMINISTERED SELF-CARE BY EATING BREAKFAST WHICH HELPED TO RELIEVE HER SYMPTOMS. THE PT CLAIMED THAT IF HER PRE-BREAKFAST BLOOD GLUCOSE READING HAD BEEN LOWER, SHE WOULD HAVE EATEN BREAKFAST BEFORE TAKING THE INSULIN. AS A RESULT OF THE EVENT, THE PT STATED THAT SHE HAS BEEN DECREASING HER SLIDING-SCALE INSULIN DOSAGES. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HER FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE PT ALLEGED THAT SHE TOOK TOO MUCH INSULIN BASED ON AN INACCURATE HIGH METER READING AND THEN DEVELOPED SYMPTOMS OF SWEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2839006

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R