BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFILL TEST STRIPS

    MDR report key: 686909 · Received March 9, 2006

    Report

    Report Number
    1826988-2006-00159
    Event Type
    Malfunction
    Date Received
    March 9, 2006
    Date of Event
    March 3, 2006
    Report Date
    March 3, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD BEEN GETTING HIGH GLUCOSE READINGS IN THE 300-400'S (MG/DL). WHEN THE CUSTOMER WOULD RETEST, GLUCOSE READINGS WOULD BE IN TGHE 122-190 MG/DL RANGE. THE DIFFERENCES BETWEEN SOME OF THESE VALUES FALL IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THE CUSTOMER ALSO STATED THAT SHE WAS GIVEN 5 MICROFILL TEST STRIPS IN A TIGHT SEAL BAG FROM BENSONS, WHERE SHE OBTAINED HER METER. SHE ADDED THOSE STRIPS TO HER BOTTLE AT HOME. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS DUE TO THE ERRATIC READINGS. THE STRIPS ARE TO BE RETURNED FOR EVALUATION. AND REPLACEMENT STRIPS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFILL TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098 5JB3B11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN