BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-COM V5.0

    MDR report key: 21906959 · Received April 25, 2025

    Report

    Report Number
    9610824-2025-00015
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969234417
    PMA / PMN Number
    BK180275
    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 INTIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN INCORRECT TEST RESULT WAS RELEASED BY IH-COM TO THE LIS. THE SAMPLE WAS A POS IN IH-COM AND RELEASED TO THE LIS AS A A POSITIVE BUT WAS B POS. BECAUSE THE RH WAS STILL PENDING, NO INCORRECT TEST RESULT WAS COMMUNICATED AND NO PATIENT WAS HARMED. TRACE FILES WERE COLLECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND ARE STILL UNDER INVESTIGATION. OUR PREMILARY INVESTIGATION SHOWS THAT THE INCORRECT BLOOD GROUP INTERPRETATION STORED IN THE IH-COM IS DUE TO A MANUAL CHANGE TO THE ABO INTERPRETATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN INCORRECT TEST RESULT WAS RELEASED BY IH-COM TO THE LIS. THE SAMPLE WAS A POS IN IH-COM AND RELEASED TO THE LIS AS A POSITIVE BUT WAS B POS. BECAUSE THE RH WAS STILL PENDING, NO INCORRECT TEST RESULT WAS COMMUNICATED AND NO PATIENT WAS HARMED. TRACE FILES WERE COLLECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND ANALYZED. THIS ANALYSIS SHOWED THAT THE ABO INTERPRETATION CONDUCTED BY THE IH-1000 INSTRUMENT WAS "ABO NOT INTERPRETABLE" DUE TO THE CELL B WHICH WAS READ AS POSITIVE. THE TRACE FILES ALSO SHOW THAT AT 07:26, THE USER CHANGED THE ABO INTERPRETATION TO "A", THE WELL REACTION FOR THE CELL B WELL TO NEGATIVE AND THE ABO INTERPRETATION TO "A". THIS MANUALLY ALTERED RESULT WAS SAVED BY THE USER WITH A MANDATORY SAMPLE COMMENT DUE TO THE DISCREPANT RESULT. THE INCORRECT BLOOD GROUP INTERPRETATION STORED IN THE IH-COM OCCURRED DUE TO A MANUAL CHANGE IN THE ABO INTERPRETATION THE IH-1000 AND IH-COM WORKED AS EXPECTED AND INTERPRETED THE RESULTS AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480231 IH-COM V5.0 IH-COM V5.0 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 07611969234417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IH-1000, SN (B)(6)| IH-1000, SN (B)(6)