BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE HB 301 SYSTEM

    MDR report key: 18756180 · Received February 22, 2024

    Report

    Report Number
    3003044483-2024-00001
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    October 1, 2023
    Report Date
    April 17, 2024
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    PMA / PMN Number
    BK060048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COULD NOT IDENTIFY EXACTLY WHICH OF THEIR ANALYZERS HAD BEEN USED AT THE TIME OF THE INCIDENT AND THEREFORE RETURNED THE 3 DEVICES THAT COULD HAVE BEEN USED. TWO OF THE ANALYZERS (B)(6) WERE INVESTIGATED AND FOUND TO BE PERFORMING ACCORDING TO SPECIFICATIONS AND NO MALFUNCTION COULD BE FOUND ON THOSE. THE THIRD ANALYZER (B)(6) PERFORMED WITHIN SYSTEM REQUIREMENT SPECIFICATION BUT MEASURED APPROXIMATELY 0.5 G/DL TOO HIGH. FURTHER INVESTIGATION CONFIRMED THAT THIS DEVIATION WAS CAUSED BY UNAUTHORIZED OPENING OF THE ANALYZER LEADING TO THE ANALYZER'S OPTIC MODULE BEING DAMAGED. THE OPTIC MODULE INCLUDES THE LIGHT DETECTOR BOARD WHICH AFFECTS A/D CONVERTER FUNCTIONING.

    Description of Event or Problem · 0

    HEMOCUE AB RECEIVED A COMPLAINT ABOUT AN INCIDENT DURING A BLOOD DONATION. THE DONOR'S FIRST HEMOCUE (HB) READING WAS 10.3G/DL. SHE PERMITTED A SECOND STICK AND IT CAME BACK AS 13.3G/DL. SHE QUALIFIED FOR AND AGREED TO A DOUBLE RED COLLECTION (WHICH EFFECTIVELY REMOVES TWO RBC UNITS BY APHERESIS). SHE FELT LIGHTHEADED AFTERWARDS AND ENDED UP IN THE ER A COUPLE OF DAYS LATER WHERE HER VENOUS HEMOGLOBIN WAS CLOSE TO 7G/DL. SHE WAS HOSPITALIZED, TREATED FOR ANEMIA AND DISCHARGED. THE DONOR IS CONTINUING TREATMENT WITH HER PRIMARY CARE PHYSICIAN AND HAS DECLINED TO PROVIDE ANY SUBSEQUENT FOLLOW UP INFORMATION. THE END USER ASSUMPTION IS THAT THE SECOND HB VALUE WAS ERRONEOUSLY HIGH. THE END USER HAD THREE ACTIVE ANALYZERS (SERIAL NUMBERS: (B)(6) AT THE SITE DURING THE TIME OF THE EVENT AND IT IS NOT KNOWN WHICH OF THEM WAS USED ON THIS DONOR. THE END USER HAS INDICATED THAT THEY DO NOT BELIEVE THERE ARE ANY ISSUES WITH THE HEMOCUE DEVICES AND HAVE NOT RETURNED ANY OF THEM FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61536 HEMOCUE HB 301 SYSTEM HEMOGLOBIN TEST SYSTEM GKR HEMOCUE AB 121804 2204220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other