BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1051825 · Received May 23, 2008

    Report

    Report Number
    2939301-2008-00914
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    April 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    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 EVAL, 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

    ON APRIL 30, 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER IS GIVING INACCURATE ERRATIC READINGS. THIS MEDICAL AFFAIRS SPECIALIST WAS ABLE TO CONTACT THE PT TO CLARIFY INFO OBTAINED FROM THE INITIAL CALL ON MAY 19, 2008. THE REPORTED ISSUE FIRST OCCURRED WHILE THE PT WAS ON A TRIP TO DISNEYLAND AND WAS TESTING WITH THE LFS METER AND A CONTINUOUS MONITORING BLOOD GLUCOSE DEVICE ON FOUR DAYS PRIOR TO ORIGINAL DATE. AT AN UNSPECIFIED TIME ON THE SAME DAY, THE PT REPORTED BLOOD GLUCOSE RESULTS OF "320 AND 112 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 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. ACCORDING TO THE PT, SHE INCREASED HER NOVOLOG INSULIN BY 2 UNITS BASED ON THE "320 MG/DL" BLOOD GLUCOSE READING. THE PT DOES NOT RECALL WHAT READINGS SHE OBTAINED ON THE CONTINUOUS BLOOD GLUCOSE MONITORING DEVICE. WITHIN 10 MINUTES, THE PT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SWEATY, SHAKY, WEAK, CONFUSED AND FELT LIKE PASSING OUT." THE PT TESTED HER BLOOD GLUCOSE AGAIN AND OBTAINED A BLOOD GLUCOSE READING OF "112 MG/DL AND 80 MG/DL." THE SYMPTOMS ABATED AFTER THE PT HAD SOME BEVERAGE/FOOD. SINCE SHE HAS RECEIVED THE NEW METER AND TEST STRIPS, SHE HAS NOT HAD ANY ISSUES WITH THE REPORTED ISSUE WITH THE LFS PRODUCTS. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS NOT CLEANED APPROPRIATELY, THE BLOOD SAMPLE WERE TAKEN FROM APPROVED TESTING SITES, AND THE REPORTED METER READINGS COULD NOT BE FOUND IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2730746

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R