BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1023251 · Received March 31, 2008

    Report

    Report Number
    2939301-2008-00418
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA 2 METER WAS GIVING HER INACCURATE HIGH READINGS. THE MEDICAL AFFAIRS SPECIALIST SPOKE TO THE PATIENT ON MARCH 26, 2008 AND VERIFIED THE FOLLOWING INFORMATION. ACCORDING TO THE PATIENT, THE REPORTED ISSUE STARTED ON THE PRIOR TO ORIGINAL DATE AT AROUND 6:00 PM. THE PATIENT TESTED HER BLOOD SUGAR AND RECEIVED A READING OF 280 MG/DL. SHE ADMINISTERED ABOUT 6 UNITS OF NOVALOG INSULIN BASED ON THAT READING. ABOUT AN HOUR LATER, THE PATIENT STARTED FEELING SHAKY AND SWEATY. THE PATIENT MENTIONED THAT SHE WAS AWARE THAT HER BLOOD SUGAR WAS LOW AT THAT TIME. THEREFORE, SHE ATE AND DRANK SOMETHING AND FELT BETTER ABOUT AN HOUR AFTER THAT. SHE DENIED OF RECEIVING MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. SHE WAS NOT TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE UNIT OF MEASUREMENT WAS SET CORRECTLY, SHE WAS USING CORRECT TECHNIQUE TO TEST AND TO CLEAN THE PUNCTURE AREA, THE PATIENT WAS READING THE METER RIGHT SIDE UP AND THE SAMPLE WAS DRAWN FROM AN APPROVED SOURCE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PATIENT CLAIMED OF ADMINISTERING HIGHER AMOUNT OF INSULIN DUE TO GETTING A HIGHER READING ON THE REPORTED LFS METER AND LATER DEVELOPED SHAKINESS AND SWEATINESS, SYMPTOMS, WHICH CAN BE ASSOCIATED WITH SEVERE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R