BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-1000 AUTOMATED ANALYZER SYSTEM

    MDR report key: 24245755 · Received February 3, 2026

    Report

    Report Number
    9610824-2026-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 4, 2026
    Report Date
    February 20, 2026
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969205493
    PMA / PMN Number
    BK170019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 INCORRECT INTERPRETATION ON ANTIBODY DETECTION RESULTS WHEN USING IH-CELL I-II-III ON THEIR IH-1000 INSTRUMENT. VISUALLY, CELLS 1 AND 2 OF IH-CELL I-II-III APPEARED WEAKLY POSITIVE, CELL 2 WAS INTERPRETED AS NEGATIVE BY THE INSTRUMENT. THE AFFECTED INSTRUMENT WAS CHECKED. ACCORDING TO THE INVESTIGATION PERFORMED, THERE IS NO ERROR DURING THE PROCESSING OF THE TEST AND NO PIPETTING ERRORS WERE RECORDED, THE VOLUMES OF PLASMA AND REAGENT RED BLOOD CELLS WERE WITHIN THE SPECIFICATIONS. THE GEL CARD IMAGE DOES NOT APPEAR MISALIGNED, THEREFORE A GRIPPER POSITIONING OR ADJUSTMENT ISSUE CAN BE RULED OUT. VISUALLY, THE REACTION APPEARS WEAKLY POSITIVE, HOWEVER THE INSTRUMENT INTERPRETED THE CELL 2 AS NEGATIVE. BASED ON THE AVAILABLE DATA, THIS DOES NOT APPEAR TO BE A REAGENT-RELATED ISSUE. THE FINDINGS ARE MORE CONSISTENT WITH AN IMAGE ANALYSIS / ALGORITHM INTERPRETATION DISCREPANCY. THE RAW GEL CARD IMAGE HAS BEEN SHARED WITH OUR R&D DEPARTMENT AND THEY CONFIRMED WITH AN IMAGE ANALYSIS THAT THE FALSE NEGATIVE RESULT IS DUE TO THE ATYPICAL SHAPE OF THE REACTION. TWO POINTS ARE LEADING TO THE FALSE NEGATIVE INTERPRETATION: PACKED RED CELLS DOING LIKE A THICK LINE, ZONE WITHOUT RED BLOOD CELLS THAT IS ENHANCING THE PACKED RED CELLS. THESE 2 POINTS ARE TRICKING THE ALGORITHM, WHICH IS WRONGLY ESTIMATING THE TOP OF THE PELLET. THE REACTION IS ALSO JUST UNDER THE "?" LIMIT BASED ON TEXTURE EVALUATION: 2808 FOR A LIMIT OF 3000, CLOSE TO RETURN A "?" INTERPRETATION. BASED ON THIS, THE MISINTERPRETATION IS NOT DUE TO A CAMERA MISADJUSTMENT BUT TO AN ALGORITHM-RELATED INTERPRETATION ISSUE DUE TO THE ATYPICAL SHAPE OF THE 1+ REACTION. ON THE BASIS OF OUR OBSERVATION, THE INFORMATION AND DATA PROVIDED BY THE CUSTOMER, THE ISSUE REPORTED BY THIS CUSTOMER IS LIKELY SOFTWARE RELATED. THEREFORE, A NONCONFORMITY (NC-002463) HAS BEEN OPENED TO ESCALATE THIS ISSUE TO OUR SOFTWARE TEAM FOR FURTHER INVESTIGATION. THIS IS AN ISOLATED CASE, INTRISIC TO THE LIMIT OF THE INTERPRETATION ALGORITHM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INCORRECT INTERPRETATION ON ANTIBODY DETECTION RESULTS WHEN USING IH-CELL I-II-III ON THEIR IH-1000 INSTRUMENT. VISUALLY, CELLS 1 AND 2 OF IH-CELL I-IIII APPEARED CLEARLY POSITIVE, CELL 2 WAS INTERPRETED AS NEGATIVE BY THE INSTRUMENTS. THE INVESTIGATION OF THIS CASE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107168 IH-1000 AUTOMATED ANALYZER SYSTEM IH-1000 AUTOMATED ANALYZER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 07611969205493

    Patients

    Seq Age Sex Outcome Treatment
    1