BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1433101 · Received August 4, 2009

    Report

    Report Number
    2939301-2009-04701
    Event Type
    Injury
    Date Received
    August 4, 2009
    Report Date
    July 13, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA 2 METER READ IMPRECISELY. THE MEDICAL SURVEILLANCE SPECIALIST WAS NOT ABLE TO CONTACT THE PATIENT TO OBTAIN/CLARIFY INFORMATION. THE PATIENT MENTIONED RESULTS OF 252, 400, AND APPROXIMATELY 350 MG/DL PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE OF THE EXPECTED VALUE OF <=20%. HE SAID THAT AT AN UNKNOWN TIME AFTER THE ISSUE STARTED, HE FELT SYMPTOMS OF SWEATING. THE PATIENT WAS UNABLE/UNWILLING TO ANSWER OTHER QUESTIONS. HE DID NOT SAY WHAT HE DID REGARDING DIABETES MANAGEMENT OR IF HE RECEIVED ANY TREATMENT, DUE TO THE PRODUCT ISSUE. HE DID NOT SAY WHEN HE OBTAINED THE READINGS. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE PUNCTURE AREA WAS CLEANED CORRECTLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND CALIBRATION CODE NUMBER. A QUALITY CONTROL TEST WAS PERFORMED, WITH FAILING RESULTS. THE RESULTS WERE VERIFIED IN THE METER MEMORY. ALTHOUGH DETAILS OF THE PATIENT'S TREATMENT AND MANAGEMENT OF DIABETES ARE UNKNOWN, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THE RESULTS WERE IMPRECISE AND STATED HE LATER FELT SYMPTOMS THAT CAN BE INDICATIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2892156

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening