BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1142761 · Received August 27, 2008

    Report

    Report Number
    2939301-2008-01940
    Event Type
    Injury
    Date Received
    August 27, 2008
    Report Date
    August 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. SERIAL# NOT PROVIDED.

    Description of Event or Problem · 1

    IN 2008 AT 12:32 PM, A LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT AN ONE TOUCH ULTRA2 METER HAD AN ERROR MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT TO OBTAIN ADDITIONAL INFO. THE PT NORMALLY TESTS HER BLOOD GLUCOSE THREE TIMES A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. ON FIVE DAYS EARLIER, THE PT REPORTEDLY RECEIVED AN ERROR MESSAGE (DOES NOT REMEMBER WHICH ERROR MESSAGE IT WAS) ON THE SUBJECT METER. SOMETIME AFTER THE REPORTED METER ISSUE BEGAN, THE PT REPORTEDLY DEVELOPED SYMPTOMS OF "ITCHY AND THIRSTY". SHE CLAIMED THAT SHE "DOUBLED THE DOSE OF GLUCOPHAGE AND METFORMIN." THE PT DOES NOT HAVE A BACKUP METER TO TEST HER BLOOD SUGAR WITH. ON THE DAY PRIOR TO ORIGINAL DATE, THE PT VISITED HER HEALTHCARE PROFESSIONAL (HCP) (UNSPECIFIED REASON), BUT SHE WAS REPORTEDLY GIVEN A BLOOD GLUCOSE TEST AND WAS ADVISED BY HER HCP NOT TO PERFORM SELF-TREATMENT WITHOUT HIS CONSENT. THE BLOOD GLUCOSE TEST RESULT WAS NOT PROVIDED. DURING TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW OUT OF BOX PRODUCT. THE REPORTED METER ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA 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 2759541

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening