BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCUCHEK

    MDR report key: 490325 · Received October 21, 2003

    Report

    Report Number
    490325
    Event Type
    Other
    Date Received
    October 21, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    CFR
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    STAFF WERE USING ACCUCHEK GLUCOSE METERS TO OBTAIN GLUCOSE LEVEL ON A PT. ALL 3 ACCUCHEK GLUCOSE METERS USED GAVE SOME ERROR MESSAGE "BAD STRIP." THE STAFF TESTED THE ACCUCHEK GLUCOSE METERS WITH 2 DIFFERENT NEWLY OPENED BOTTLE OF STRIPS. LAB WAS CALLED AND TESTED THE ACCUCHEK GLUCOSE METERS WITH THE CONTROL SOLUTIONS AND DETERMINED THE METERS WERE FUNCTIONAL. CHEMISTRY STAFF GOT A CBA SPECIMEN FROM HEMATOLOGY AND PROCESSED FOR GLUCOSE, WITH RESULTS OF 0.1 MG/DL. THE STAFF WAS NOTIFIED OF THE PANIC VALUE. THE PT WAS TREATED AND THE NEXT GLUCOSE SPECIMEN WAS TAKEN WITH ACCUCHEK GLUCOSE METERS WITH A RESULT OF 104 MG/DL. THE LAB CALLED ROCHE ABOUT "BAD STRIP" ERROR MESSAGE. ROCHE THOUGHT THE STRIP WAS BAD BECAUSE THERE WAS NO DETECTABLE GLUCOSE IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK ACCUCHEK GLUCOSE METER CFR ROCHE DIAGNOSTICS CORPORATION INFORM *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other