BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC

    MDR report key: 419315 · Received September 23, 2002

    Report

    Report Number
    2939301-2002-09738
    Event Type
    Malfunction
    Date Received
    September 23, 2002
    Report Date
    September 18, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S OT TEST STRIPS FOR THEIR OT BASIC METER WERE DISCOLORED. CUSTOMER ALSO REPORTED INACCURATE READINGS. THE BASIS FOR THE INACCURACY WAS ON A COMPARISON TO NORMAL READINGS. THIS IS NOT CONSIDERED A VALID COMPARISON. CUSTOMER EATING AND TAKING ACTION BASED ON LOW BLOOD READING (O MG/DL). THE CUSTOMER DID NOT EXPERIENCE ANY ADVERSE EVENTS OR SERIOUS INJURY. THE METER HAS BEEN REPLACED FOR THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 192265A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR