BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 647197 · Received November 16, 2005

    Report

    Report Number
    2939301-2005-05202
    Event Type
    Injury
    Date Received
    November 16, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 5, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY REPORTER CONTACTED LIFESCAN ALLEGING THAT THE LAY PT'S METER (UNKNOWN TYPE) WAS READING INACCURATELY LOW. MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER TO THE PT, AS SHE COULD NOT BE REACHED VIA PHONE. THE REPORTER SAID THE PT OBTAINED RESULTS OF 160, 208, AND 197 MG/DL AT HOME ON THE REPORTED METER BEFORE FEELING DIZZY AND SHORT OF BREATH. THE TIME DIFFERENCE BETWEEN THE READINGS WAS NOT PROVIDED. NO INFORMATION REGARDING THE PT'S DIABETES TREATMENT REGIMEN WAS PROVIDED. THE PT TOOK NO ACTION TO AFFECT HER BLOOD GLUCOSE LEVEL FOLLOWING USE OF THE PRODUCT. THE PT WAS TAKEN TO THE HOSPITAL WHERE A RESULT OF 450 MG/DL WAS OBTAINED. THE TIME DIFFERENCE BETWEEN THE TESTS ON THE REPORTED METER AND THE HOSPITAL TEST WAS NOT PROVIDED. THE PT WAS TREATED WITH 25 UNITS OF 70/30 INSULIN. THE METER WAS REPLACED. THE COMPLAINT IS REPORTED AS AN ADVERSE EVENT, AS THE REPORTED PRODUCT MAY HAVE READ INACCURATELY LOW DELAYING TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R