BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201 DM SYSTEM

    MDR report key: 8027935 · Received November 1, 2018

    Report

    Report Number
    3003044483-2018-00004
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 2, 2018
    Report Date
    November 20, 2018
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    PMA / PMN Number
    K041230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE SEVERAL REMINDERS NO GOODS WERE SENT IN BY THE CUSTOMER AND THERE WAS NO RESPONSE TO QUESTIONS SENT BY HEMOCUE AB. SINCE THERE IS NO POSSIBILITY TO INVESTIGATE THE ACTUAL DEVICE, A DEVICE HISTORY RECORD CHECK WAS DONE FOR THE ANALYZER AND MICROCUVETTES, NOTHING RELATED TO THE CUSTOMER PROBLEM WAS FOUND. THE INVESTIGATION WAS DONE ON RETAINED MICROCUVETTES OF THE SAME BATCH AS THE CUSTOMERS, THE RESULT WERE ALL WELL WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    HEMOCUE RECEIVED A COMPLAINT THAT THE ANALYZER DOES NOT CORRELATE WITH CHEMISTRY ANALYZER (SIEMENS OR STRIPMETER). RESULTS FROM TWO PATIENTS WERE RECEIVED, FOR BOTH PATIENTS IT SHOWED >100 MG/DL ON HEMOCUE AND <70 MG/DL ON LAB ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870245 HEMOCUE GLUCOSE 201 DM SYSTEM GLUCOSE TEST SYSTEM LFR HEMOCUE AB 121422

    Patients

    Seq Age Sex Outcome Treatment
    1