BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1020939 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00406
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS 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/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THAT THE ONE TOUCH ULTRA 2 METER IS GIVING INACCURATE HIGH READINGS. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT TESTS HER BLOOD GLUCOSE MORE THAN 4 TIMES PER DAY. THE PATIENT TAKES INSULIN BASED ON HER BLOOD GLUCOSE READING. APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LFS, THE PATIENT CLAIMED SHE TOOK AN UNSPECIFIED AMOUNT OF HUMULIN INSULIN BASED ON AN ALLEGED INACCURATE HIGH READING OF "400 MG/DL" AT 8 AM. THE PATIENT DID NOT HAVE ANY SYMPTOM AT THE TIME. THE PATIENT DROPPED HIS WIFE OFF AT THE STORE AROUND 10 AM AND WAS SUPPOSED TO DRIVE TO THE POST OFFICE AND COME BACK TO PICK HER UP. ACCORDING TO THE WIFE, THE PATIENT BECOME CONFUSED AND WAS DRIVING AROUND. NOTHING LOOKED FAMILIAR TO THE PATIENT, AS HE FELT "WEIRD". THE PATIENT PUT HIS CAR INTO PARK AT A STOP SIGN. HOURS LATER, THE PATIENT WAS AWAKEN BY THE PARAMEDICS. THE WIFE INDICATED THAT THE PARAMEDIC WOKE THE PATIENT UP FROM A DEEP SLEEP. THE PATIENT WAS GIVEN GLUCAGON INJECTION AFTER HE WAS TESTED AT "27 MG/DL" ON A PARAMEDIC METER. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) VERIFIED THAT THE PUNCTURE AREA WAS CLEANED CORRECTLY, AND THE TESTING TECHNIQUE WAS CORRECT. HOWEVER, THE REPORTER WAS UNWILLING/UNABLE TO PROVIDE THE METER SETTING FOR UNIT OF MEASUREMENT AT TIME OF TESTING AND VERIFY RESULTS IN METER'S MEMORY. THE CCA INDICATED THAT THE PATIENT HAS BEEN USING EXPIRED TEST STRIPS. USE OF EXPIRED TEST STRIPS CAN CAUSE ONE'S BLOOD GLUCOSE RESULTS TO BE INACCURATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT WAS TREATED FOR HYPOGLYCEMIA AFTER THE PATIENT BASED HIS INSULIN INTAKE ON AN ALLEGED INACCURATE HIGH READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2582261

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R