BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1163085 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02254
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 8, 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 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 STIRPS 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/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONE TOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON SEPTEMBER 11, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT ON THE DAY PRIOR TO ORIGINAL DATE AT 8:30 AM, SHE OBTAINED BLOOD GLUCOSE READINGS OF "177, 161, AND 168 MG/DL" ON THE SUBJECT METER PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. AS A RESULT OF THE VALUES SHE OBTAINED, THE PT STATED SHE TOOK 1 METFORMIN (500MG) PILL. THE PT MENTIONED IF HER MORNING BLOOD GLUCOSE LEVEL IS LESS THAN "160 MG/DL" SHE DOES NOT TAKE THIS MEDICATION. AT 11:15 AM THAT SAME MORNING, WHILE AT CHURCH, THE PT REPORTED THAT SHE BEGAN TO SHAKE "VIOLENTLY" AND HER VISION WAS "CLOUDY." THE PT WAS UNABLE TO TEST HER BLOOD GLUCOSE BECAUSE SHE DID NOT HAVE HER METER WITH HER. HOWEVER, BECAUSE SHE FELT SHE WAS HAVING A "HYPO ATTACK" SHE TREATED HERSELF WITH A NUTRITIONAL DRINK, PUNCH SWEETENED WITH SUGAR, AND TOOK 6 SUGAR PILLS. THE PT CLAIMED SHE FELT BETTER ABOUT 1/2 HOUR LATER. THE PT STATES SHE HAD MADE NO CHANGES TO HER DIET OR ACTIVITY LEVEL THAT MORNING. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE PROPER UNIT OF MEASURE SETTING (MG/DL), AND THAT THE PT WAS CLEANING THE PUNCTURE AREA PROPERLY. HOWEVER, THE CCA NOTED THAT THE PT WAS USING THE INCORRECT TESTING TECHNIQUE. REPLACEMENT PRODUCTS WERE SENT TO THE PT. THIS COMPLAINANT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2846148

    Patients

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