BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1242231 · Received November 19, 2008

    Report

    Report Number
    2939301-2008-03191
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 13, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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/REPORTER IN GERMANY CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING THE ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST SENT FOLLOW UP QUESTIONS. THE REPORTER STATED THAT ON NOVEMBER 6 AT 6:05 PM THE REPORTER TESTED THE PATIENT'S BLOOD SUGAR AND OBTAINED A RESULT OF 460 MG/DL. HE REPORTEDLY FELT THIS RESULT WAS TOO HIGH SO HE TESTED A MINUTE LATER AND OBTAINED A RESULT OF 357 MG/DL WITH A DIFFERENT ONE TOUCH ULTRA 2 METER. THE REPORTER STATES THAT THE PATIENT'S NORMAL READINGS AROUND THIS TIME ARE ABOUT 200 MG/DL. BASED ON THE 357 MG/DL READING, THE REPORTER ALLEGEDLY INJECTED THE PATIENT WITH AN AMOUNT OF INSULIN BASED ON THE SLIDING SCALE. THE PATIENT ATE HER NORMAL DINNER AFTER THOSE READINGS 6:05 PM. HE WAS NOT WILLING TO GIVE THE EXACT DOSE THAT HE GAVE. THE REPORTER MENTIONS THAT HE HAS BEEN DIABETIC FOR 30 YEARS SO HE IS WELL TRAINED IN MANAGING DIABETES. THE PATIENT'S PARENTS TEST THE PATIENT SIX TIMES PER DAY. ABOUT 1.5 HOURS AFTER INJECTING THE INSULIN DOSE, HE CHECKED HIS DAUGHTER'S BLOOD GLUCOSE AGAIN BECAUSE THE PATIENT'S MOTHER NOTICED THE PATIENT'S FACE TURNED PALE, WHICH SHE SAYS ARE INDICATIVE OF HYPOGLYCEMIA FOR THE PATIENT. THE REPORTER REPORTEDLY OBTAINED A RESULT OF 63 MG/DL AT THAT TIME AND GAVE THE PATIENT ORAL GLUCOSE. HE SAYS THAT SOON AFTER THE PATIENT WAS GIVEN ORAL GLUCOSE, SHE FELT FINE. THE REPORTER SAYS THE PATIENT HAD THE FLU SINCE OCTOBER 30, BUT SHE DOESN'T TAKE ANY MEDICATION FOR IT. THE PATIENT DID NOT HAVE ANY DIABETIC SYMPTOMS BEFORE THE TIME SHE HAD SYMPTOMS ON THE DAY PRIOR TO ORIGINAL DATE AFTER DINNER. THE PATIENT DOES NOT USUALLY HAVE SYMPTOMS WITH THE FLU. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THAT THE PATIENT'S TESTING TECHNIQUE IS CORRECT AND THE PATIENT CLEANED THE PUNCTURE AREA CORRECTLY. THE RESULTS WERE VERIFIED IN THE METER MEMORY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER ALLEGED THE PATIENT EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AFTER THE REPORTER ADMINISTERED INULIN BASED ON AN ALLEGED HIGH READING. IN ADDITION, THE PATIENT HAD TO BE GIVEN ORAL GLUCOSE AFTER THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening| R