BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEX2 METER US

    MDR report key: 442121 · Received January 30, 2003

    Report

    Report Number
    1810909-2003-00042
    Event Type
    Other
    Date Received
    January 30, 2003
    Date of Event
    January 13, 2003
    Report Date
    January 24, 2003
    Manufacturer
    BAYER HEALTHCARE LLC/DIAGNOSTIC DIVISION
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED INDICATING THAT CO'S METER READS 230 POINTS LOWER THAN THE LAB TEST. THE CONTACT HAS BEEN TESTING AND MEDICATING THE CUSTOMER BASED ON THE READINGS OBTRAINED FROM CO'S METER. ADDITIONALLY, THE CONTACT INDICATED THAT THE METER HAS BEEN REQUIRING FREQUENT BATTERY REPLACEMENT. THE CONTACT DID NOT HAVE THE REQUISITE SUPPLIES ON HAND TO CHECK THE PROPER FUNCTIONALITY OF THE TEST SENSORS. A REQUEST WAS MADE TO RETURN THE METER AND REMAINING TEST SENSORS FOR EVAL. IN THE MEANTIME, A REPLACEMENT UNIT WAS SENT TO THE CUSTOMER. THE CONTACT WAS INVITED TO CALL CO'S 24/7 CUSTOMER SERVICE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEX2 METER US BLOOD GLUCOSE METER CFR BAYER HEALTHCARE LLC/DIAGNOSTIC DIVISION 3952H *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN