BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1465104 · Received September 4, 2009

    Report

    Report Number
    2939301-2009-05541
    Event Type
    Injury
    Date Received
    September 4, 2009
    Date of Event
    August 22, 2009
    Report Date
    August 24, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    ON AUGUST 24, 2009, THE LAY-USER/PT CONTACTED LIFE SCAN (LFS), ALLEGING THAT THE ONE TOUCH ULTRA2 METER IS GIVING INACCURATE READINGS. THIS MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CONTACT THE PT ON SEPTEMBER 2, 2009, TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PT TESTS HER BLOOD GLUCOSE MORE THAN 3 TIMES PER DAY AND MANAGES HER DIABETES WITH ORAL MEDICATION (GLIPIZIDE) AND NOVOLOG INSULIN-NO ADJUSTMENTS. IN 2009, THE PT OBTAINED BLOOD GLUCOSE RESULTS OF "355, 222, 195, AND 138 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 5 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. IN THE NEXT DAY AT 10 AM, THE PT JUST FINISHED BREAKFAST (BACON EGGS, NO CARBS) AND TESTED AT "146 MG/DL" ON THE SUBJECT METER, WHICH THE PT FELT WAS INACCURATELY HIGH. WITHIN MINUTES, THE PT REPORTEDLY FELT FAINT. THAT PT CLAIMED SHE PASSED OUT, FELL DOWN, AND HIT HER HEAD ON THE FLOOR. THE PT WOKE UP SHORTLY AFTER. THE PT FELT THAT HAD SHE OBTAINED AN ACCURATE READING PRIOR TO HER SYMPTOMS, SHE COULD HAVE HAD SOME JUICE AND PREVENTED THE ALLEGED HYPOGLYCEMIC INCIDENT. THE PT DID NOT PARTICIPATE IN ANY STRENUOUS ACTIVITY IN THE DAY OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS NOT CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE PASSED OUT MINUTES AFTER SHE OBTAINED AN INACCURATE READING ON THE LFS METER. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2877205

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening