BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METER C - OT BASIC ORIGINAL

    MDR report key: 379803 · Received February 4, 2002

    Report

    Report Number
    2939301-2002-01462
    Event Type
    Malfunction
    Date Received
    February 4, 2002
    Report Date
    October 20, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER CALLED LFS IN 2001 ALLEGING THAT THE CUSTOMER'S OT BASIC WAS GIVING INACCURATE ERRATIC READINGS. PER CCR, THE FOLLOWING INFO WAS DOCUMENTED: CUSTOMER NOT ALLEGING ANY HARM. NO SYMPTOMS. THE CUSTOMER DID BACK TO BACK TESTS ON SAME METER WITH READINGS OF 152, 148, 248MG/DL. THE CUSTOMER CALLED DOCTOR (UNCLEAR AS TO WHEN AND WHAT TREATMENT) CUSTOMER ALSO HAVING PROBLEMS WITH THE METER READING LOW CHECKSTRIP TESTS. (UNCLEAR IF FAILING LOW OR IF LOW WITHIN RANGE) CUSTOMER HAD MORE THAN ONE MEDICATION CHANGE DUE TO THIS READING ON THE METER. CCR REPLACED WITH A OT BASIC METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR