BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1081850 · Received July 18, 2008

    Report

    Report Number
    1826988-2008-00781
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 WHICH CONFIRMS EXPOSURE OF THE REAGENT. QA ALSO FOUND THAT ONE TEST STRIP READ 79 MG/DL LOW, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HIS NEW CONTOUR METER WAS READING HIGH COMPARED TO HIS OLDER CONTOUR METER. HE ALSO ALLEGED THAT HE RECEIVED SOME CONTROL TEST RESULTS THAT WERE HIGH, OUT OF SPECIFICATION. THE INITIAL CALL DID NOT MEET THE REPORTING CRITERIA. TROUBLESHOOTING SHOWED THE CUSTOMER'S CONTOUR SYSTEM TO EB OPERATING AS DESIGNED, BUT HIS TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080D 7JC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK