BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243800 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03200
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    September 28, 2008
    Report Date
    November 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    THE LAY USER/PATIENT CONTACTED LIFESCAN, ALLEGING THAT THE ONE TOUCH ULTRA METER READ "INACCURATELY HIGH." THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE'S (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN IN 2008 AT 11:59PM. DURING THAT TIME, THE PATIENT REPORTEDLY OBTAINED AN "INACCURATE HIGH" READING OF "303MG/DL" ON THE SUBJECT METER. THE PATIENT STATED THAT HE TOOK INSULIN (UNKNOWN TYPE AND DOSE) BASED ON THE METER READING. IT IS NOT KNOWN WHETHER THE INSULIN HE TOOK WAS PART OF HIS DIABETIC REGIMEN. ON THE SAME DAY (TIME NOT KNOWN) AFTER THE REPORTED ISSUE, THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "CONVULSIONS AND HYPOGLYCEMIC SYMPTOMS." IT IS NOT KNOWN WHETHER THE PATIENT TESTED HIS BLOOD SUGAR DURING THE REPORTED SYMPTOMS. AT AN UNSPECIFIED TIME, THE PATIENT REPORTEDLY SELF TREATED WITH FOOD AND/OR DRINK (DATE AND TIME NOT KNOWN). ON THE SAME DAY THE REPORTED ISSUE BEGAN (TIME NOT SPECIFIED), THE PATIENT REPORTEDLY OBTAINED A READING OF "238"MG/DL" ON THE EMERGENCY MEDICAL SERVICE (EMS) METER. IT IS NOT KNOWN WHETHER THIS READING WAS OBTAINED BEFORE OR AFTER THE REPORTED ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT RECEIVED ANY TREATMENT FROM THE EMS. DURING THE TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS. THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND HE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THE REPORTED RESULT OF "303MG/DL" WAS VERIFIED IN THE SUBJECT METER'S MEMORY. THERE IS NO EVIDENCE THAT THE SUBJECT METER MALFUNCTIONED. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening