BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-1000 AUTOMATED ANALYZER SYSTEM

    MDR report key: 22892308 · Received August 26, 2025

    Report

    Report Number
    9610824-2025-00028
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK170019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCORRECT TEST INTERPRETATION OF HIS IH-1000 INSTRUMENT. SAMPLE (B)(6) WAS RUN ON THE IH-1000 INSTRUMENT. IT APPEARS THAT ANTI-A FAILED TO PIPETTE PROPERLY, BUT THE INTERPRETATION WAS 4+ FOR AN OVERALL INCORRECT FORWARD INTERPRETATION.IT DOES APPEAR THAT THERE WAS A DILUTION/PIPETTING ISSUE FOR THE SUBSEQUENT ANTI-B AND ANTI-D WELLS AS WELL, AS THESE ARE ABNORMAL LOOKING. UPON REPEATING THE SAMPLE ON A DIFFERENT ANALYZER, THE RESULT WAS CORRECTLY READ AND INTERPRETED. THE INVESTIGATION OF THE INSTRUMENT'S TRACE FILES SHOWED THAT THE IH-1000 ALGORITHM WAS NOT ABLE TO DETECT THE UPPER PART OF THE GEL AND CONSIDER THE SUPERNATANT AS THE UPPER PART OF THE GEL. CONSIDERING THIS, THE ALGORITHM CONSIDERS THE MENISCUS AS RED BLOOD CELLS AND SO INTERPRETS THIS AS A 4+ RESULT. THE REASON THE WELL WAS EMPTY COULD BE DUE TO POSSIBLE DISPENCE ISSUE DUE TO MISSED CLOT BY THE IH-1000. AS THIS COMPLAINT CONCERNS A FALSE POSITIVE RESULT, WE CONSIDER THIS A NON-CONFORMITY EVEN THOUGH IT IS A KNOWN SYSTEM LIMITATION. WE ADVISED THE CUSTOMER TO CHECK FOR ANY DISPENSE ISSUES. INTERNAL NONCONFORMITY NC-000891 WAS OPENED FOR THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCORRECT TEST INTERPRETATION OF HIS IH-1000 INSTRUMENT. SAMPLE (B)(6) WAS RUN ON THE IH-1000 INSTRUMENT. IT APPEARS THAT ANTI-A FAILED TO PIPETTE PROPERLY, BUT THE INTERPRETATION WAS 4+ FOR AN OVERALL INCORRECT FORWARD INTERPRETATION. IT DOES APPEAR THAT THERE WAS A DILUTION/PIPETTING ISSUE FOR THE SUBSEQUENT ANTI-B AND ANTI-D WELLS AS WELL, AS THESE ARE ABNORMAL LOOKING. UPON REPEATING THE SAMPLE ON A DIFFERENT ANALYZER, THE RESULT WAS CORRECTLY READ AND INTERPRETED. THE INVESTIGATION OF THE INSTRUMENT'S TRACE FILES IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406776 IH-1000 AUTOMATED ANALYZER SYSTEM IH-1000 AUTOMATED ANALYZER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown