BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS

    MDR report key: 7773936 · Received August 10, 2018

    Report

    Report Number
    1826988-2018-00173
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 16, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC
    Product Code
    NBW
    PMA / PMN Number
    K121190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED TWO BOTTLES OF TEST STRIPS FROM THE SAME LOT (7HQHC31G). THE FIRST BOTTLE OF THE TEST STRIPS HAD NO STARBURST PATTERNS VISIBLE IN THE REAGENT AREA WHEN VIEWED MICROSCOPICALLY, INDICATING POTENTIAL CUSTOMER MISUSE DURING STORAGE. THE IN-HOUSE RESULTS WITH THE FIRST BOTTLE OF THE TEST STRIPS GAVE LOW RESULTS AND ERROR MESSAGE. THE ERROR MESSAGE INDICATED DETERIORATED TEST STRIPS. THE SECOND BOTTLE FROM THE SAME LOT OF THE TEST STRIPS GAVE SATISFACTORY PERFORMANCE. THE IN-HOUSE RESULTS WITH THE RETURNED HIGH CONTROL SOLUTIONS WERE ALSO LOW. IT WAS CONCLUDED THAT THE TEST STRIPS IN THE BOTTLE WERE POTENTIALLY EXPOSED TO ELEVATED TEMPERATURE OR ALLOWED TO BE EXPOSED TO EXCESS MOISTURE OUTSIDE THE BOTTLE.

    Description of Event or Problem · 1

    A NURSE IN (B)(6) RAN BLOOD TESTS ON FOUR PATIENTS USING THE CONTOUR PLUS. ONE PATIENT READ 56MG/DL AND THE OTHER THREE PATIENTS READ LO. THERE WERE NO SYMPTOMS OF HYPOGLYCEMIA, SO THE NURSE RETESTED EACH PATIENT USING A NEW BOTTLE OF STRIPS. THE RESPECTIVE READINGS WERE 182, 250, 138 AND 194MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C", "D" AND "E" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE NURSE WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613347 CONTOUR PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC 7HQHC31G

    Patients

    Seq Age Sex Outcome Treatment
    1