BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE HB 201+ SYSTEM

    MDR report key: 1260303 · Received November 10, 2008

    Report

    Report Number
    2027756-2008-00001
    Event Type
    Injury
    Date Received
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PT AT A HOSPITAL WAS LOOKING VERY UNWELL IN RECOVERY THEATRE AFTER A SURGICAL PROCEDURE, THE NURSE PERFORMED A HEMOCARE HB 201+ CAPILLARY TEST AND THE MEASUREMENT WAS 105G/L. THIS DID NOT CORRELATE WITH THE CONDITION OF THE PT AND THE HEMOCUE VALUE WAS THEREFORE, VERIFIED BY SENDING A VENOUS SAMPLE TO THE LABS. HOWEVER, BASED ON THE PT'S WORSENING CONDITION, THE PT WAS TAKEN BACK INTO THE THEATRE BEFORE THE LAB RESULT CAME BACK. THE RESULT FROM THE VENOUS SAMPLE ANALYZED AT THE LAB WAS 50G/L. LAB RESULT HAS BEEN CONFIRMED BY THE HOSPITAL TO BE ACCURATE AND PT RECOVERED AFTER TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE HB 201+ SYSTEM * GKR HEMOCUE AB * 8011509

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention