BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 SYSTEM

    MDR report key: 4293351 · Received November 24, 2014

    Report

    Report Number
    3003044483-2014-00013
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    PMA / PMN Number
    K020935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION HAS BEEN PERFORMED ON RETAINED SAMPLES BY THE MANUFACTURER ON THE SAME LOT OF HEMOCUE GLUCOSE 201 MICROCUVETTE. THE PROBLEM HAS BEEN CONFIRMED, I.E. FALSE LOW RESULTS ARE OBTAINED. THE RESULTS OBTAINED IS "0" OR VERY CLOSE TO "0" MG/DL (OR 0.0 MMOL/L). THE RESULT OF "0" MD/DL OR "0" MMOL/L IS OBTAINED INDEPENDENTLY ON THE ACTUAL GLUCOSE LEVEL OF THE SAMPLE. THE ROOT CAUSE INVESTIGATION HAS VERIFIED THAT THE REAGENT IN THE MICROCUVETTES DOES NOT CONTAIN ANY ENZYMES AND THUS NO REACTION IN THE MICROCUVETTE TAKES PLACE UPON FILLING WITH WHOLE BLOOD. THE PROBLEM IS DUE TO A HUMAN ERROR IN THE PRODUCTION OF THE REAGENT. CORRECTIVE ACTIONS HAS BEEN IMPLEMENTED TO PREVENT THIS PROBLEM TO RECUR ON OTHER LOTS. NOTE: MODEL# 110716 OF THE HEMOCUE GLUCOSE 201 MICROCUVETTES ARE NOT SOLD ON THE US MARKET. HOWEVER, OTHER MODELS ARE ON THE US MARKET.

    Description of Event or Problem · 1

    FALSE LOW MEASUREMENT RESULTS, RESULTS OF 0-15 MG/DL, ARE OBTAINED WITH LOT# 1407345 OF THE HEMOCUE GLUCOSE 201 MICROCUVETTES. NO PATIENT IMPACT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762089 HEMOCUE GLUCOSE 201 SYSTEM GLUCOSE TEST SYSTEM CGA HEMOCUE AB 110716 1407345

    Patients

    Seq Age Sex Outcome Treatment
    1