BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 249908 · Received November 12, 1999

    Report

    Report Number
    2939301-1999-00995
    Event Type
    Injury
    Date Received
    November 12, 1999
    Date of Event
    October 9, 1999
    Report Date
    October 10, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD BEEN FEELING ILL "ALL WEEK LONG." HE REPORTED THAT ON FRIDAY, 10/08/1999, HE BEGAN TO LOSE HIS HEARING AND BY THAT EVENING "I WAS COMPLETELY DEAF." AT 7:30PM ON 10/09/1999, A BLOOD TEST ON HIS ONE TOUCH BASIC METER WAS 190 MG/DL. HE WENT TO THE HOSP WHERE, 45 MINS LATER, A LAB RESULT OF 578 MG/DL WAS OBTAINED. HE WAS TREATED WITH INSULIN INJECTION AND RELEASED AT 1AM ON 10/10/1999. THE METER IS CLEANED WITH ALCOHOL, A PRACTICE THAT IS WARNED AGAINST IN THE PRODUCT'S INSTRUCTIONS FOR USE. CALIBRATION STATUS IS UNKNOWN AT THIS TIME. THE RPTR DOES NOT HAVE A CHECK STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R