BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1173439 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02350
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 09/09/08, A PT/LAYPERSON ALLEGED THAT HIS ONE TOUCH ULTRA2 METER RESULTS WERE INACCURATELY ELEVATED. THE CUSTOMER CARE ADVOCATE, CCA, REPLACED THE METER AND TEST STRIPS. BECAUSE THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS RECEIVED NO RESPONSE FROM THE PT, A LETTER HAS BEEN MAILED AND THE COMPLAINT IS CLASSIFIED BASED UPON INFO THE PT GAVE THE CCA. REPORTEDLY, THE PT TESTS ONLY 2-3 TIMES A MONTH AND TAKES ORAL DIABETES MEDICATION. ON AN UNK DATE AND TIME IN 2008, THE PT'S BLOOD GLUCOSE WAS REPORTEDLY "165 AND 125 MG/DL." AT AN UNK TIME AFTER THE RESULTS, THE PT CLAIMED HE FELT SHAKY AND DIZZY. REPORTEDLY, THE PT RECEIVED NO MEDICAL INTERVENTION. BECAUSE THE PT ALLEGEDLY HAD A SYMPTOM THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN, ALTHOUGH NO TREATMENT WAS OBTAINED, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2829147

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening