BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243791 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03207
    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
    CA, 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 ALLEGING THAT A ONE TOUCH ULTRA METER HAD A BATTERY INDICATOR ISSUE AND WOULD NOT COUNT DOWN DURING A BLOOD TEST. THE PATIENT TESTS HER BLOOD GLUCOSE 3-4 TIMES A DAY. SHE TESTS BEFORE BREAKFAST, BEFORE DINNER (AROUND 5:00-5:30 PM), AND BEFORE BEDTIME. SHE MANAGES HER DIABETES WITH SLIDING SCALE R-INSULIN BASED ON HER METER READINGS AND N-INSULIN. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUES STARTED THE DAY BEFORE, AT 5:00 PM. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE. ALTHOUGH SHE WAS UNABLE TO TEST, THE PATIENT STATED THAT SHE GUESSED ON HOW MUCH SLIDING-SCALE R-INSULIN TO TAKE. SHE REPORTEDLY TOOK 7-8 UNITS OF R-INSULIN AND THEN ATE DINNER AS USUAL 30 MINUTES LATER. ABOUT 2 HOURS AFTER TAKING THE INSULIN, THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS OF SWEATING AND FEELING WEAK. THE PATIENT ADMINISTERED SELF-CARE BY DRINKING ORANGE JUICE WHICH HELPED TO RELIEVE HER SYMPTOMS. THE PATIENT DENIED SEEKING OR RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. THE PATIENT ADMITTED THAT SHE HAD NOT REPLACED THE METER'S BATTERY ACCORDING TO THE OWNER'S MANUAL. THE ALLEGED METER ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING. THE METER WAS REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2839258

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R