BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 589563 · Received June 2, 2004

    Report

    Report Number
    2939301-2004-03366
    Event Type
    Malfunction
    Date Received
    June 2, 2004
    Report Date
    May 24, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICAL AFFAIRS HAS BEEN UNABLE TO GET A HOLD OF THE PT AND WILL BE SENDING A LETTER TO OBTAIN MORE CLINICAL INFO. PT CALLED ALLEGING LOW READINGS ON HTE LFS METER. PT WAS EXPERIENCING SYMPTOMS OF BLURRY VISION AND DRY MOUTH AND TESTED THEIR BLOOD GLUCOSE AND OBTAINED A 40MG/DL. PT ATE SOME FOOD BECASUE OF HTE LOW READING AND THEN WENT OT THE HOSP. TREATMENT WAS DOCUMENTED AS "OTHER". NO INFO ON WHAT THE READING WAS AT THE HOSP. CUSTOMER SERVICE FOUND OUT THAT PT WAS USING TEST STRIPS THAT EXPIRED IN 2000. PT HAD BEEN CLEANING THE METER PROPERLY. CHECK STRIP TEST FAILED THE CALIBRATION. BASED ON THE INFO PROVIDED, THIS CASE IS BEING REPORTED AS A MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN