BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABX MICROS 60 HEMATOLOGY ANALYZER

    MDR report key: 2920115 · Received January 9, 2013

    Report

    Report Number
    2086725-2013-00006
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 16, 2012
    Report Date
    November 6, 2012
    Manufacturer
    HORIBA ABX SAS
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CONCLUSIVE EVIDENCE THAT THE MICROS 60 REPORTED FALSELY LOW HGB RESULTS. THE QUALITY CONTROL DATA PROVIDED BY THE CUSTOMER INDICATED QUALITY CONTROLS BEFORE AND AFTER THE DATE OF THE EVENTS WERE WITHIN ESTABLISHED RANGES. HOWEVER, THE FSR NOTED THE WBC/HGB CHAMBER WAS GIVING A LOWER VOLTAGE OUTPUT THAN REQUIRED AND HE WAS UNABLE TO ADJUST THE VOLTAGE TO THE CORRECT SETTING. ONCE HE REPLACED THE WBC/HGB CHAMBER, THE VOLTAGE WAS SET TO THE CORRECT SETTING AND HE WAS ABLE TO COMPLETE THE PREVENTIVE MAINTENANCE SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO HORIBA MEDICAL (HORIBA) THAT THE ABX MICROS 60 HEMATOLOGY ANALYZER (MICROS 60) GENERATED A HEMOGLOBIN (HGB) RESULT THAT WAS DIFFERENT FROM THE INSTRUMENT AT THE HOSPITAL LAB. CUSTOMER REPORTED THAT ON (B)(6) 2012, A BLOOD SAMPLE WAS DRAWN FROM A PATIENT (CC). THE MICROS 60 GENERATED A HGB RESULT OF 8.5 G/DL ON THE PATIENT SAMPLE. CUSTOMER REPORTED THE PATIENT WAS TRANSFERRED TO THE AREA HOSPITAL FOR FURTHER EVALUATION. THE PATIENT WAS REDRAWN ON (B)(6) 2012. THE HOSPITAL LABORATORY RETURNED A HGB RESULT OF 9.0 G/DL FOR THE REDRAWN SAMPLE. IT IS UNKNOWN WHAT INSTRUMENT WAS USED AT THE HOSPITAL LAB. THE CUSTOMER REPORTED THE PATIENT RECEIVED ONE UNIT OF BLOOD AT THE HOSPITAL AFTER THE HOSPITAL LAB RESULTS WERE REPORTED. THE REFERENCE LAB RETURNED A RESULT OF 11.8 G/DL ON (B)(6). IT IS UNKNOWN WHAT INSTRUMENT WAS USED AT THE REFERENCE LAB. THE CUSTOMER ALSO STATED THAT THE QC RESULTS WERE "RUNNING LOW." HOWEVER, UPON FURTHER DISCUSSION, THE QC RESULTS WERE DETERMINED TO BE WITHIN THE EXPECTED RANGE. THE CUSTOMER REQUESTED SERVICE FOR THE INSTRUMENT BECAUSE SHE WAS CONCERNED ABOUT THE DIFFERENCE IN THE RESULTS BEING GENERATED BY THE MICROS 60 VERSUS THE OTHER RESULTS FROM THE TWO OUTSIDE LABORATORIES. THE HORIBA FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED GENERAL PREVENTIVE MAINTENANCE ON THE INSTRUMENT. THE FSR NOTED THAT HE HAD DIFFICULTY ADJUSTING THE HGB VOLTAGE TO THE CORRECT SETTING AND TO CORRECT THIS ISSUE, HE REPLACED THE WHITE BLOOD CELL / HEMOGLOBIN CHAMBER. THE FSR PERFORMED THE INSTRUMENT VALIDATION PROCEDURE AND RAN CONTROLS, ENSURING THE INSTRUMENT WAS PERFORMING PER SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12840 ABX MICROS 60 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ HORIBA ABX SAS ABXM60CT16PNBC/NP

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other