BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-COM V5.0

    MDR report key: 10710000 · Received October 21, 2020

    Report

    Report Number
    9610824-2020-00072
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 24, 2020
    Report Date
    May 31, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952342
    PMA / PMN Number
    BK180275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT. OUR INITIAL REPORT ON THIS INCIDENT WAS ISSUED FOR THE IH-INTERNAL QC BUT OUR INVESTIGATION SHOWED THAT THE ISSUE WAS CAUSED BY A SOFTWARE BUG OF THE IH-COM V5.0. SO WE AMENDED THIS FOLLOW-UP/FINAL REPORT ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RAN IH-INTERNAL QC SAMPLE 4 FOR THE WEAK D POSITIVE CONTROL, BUT THE TECH FORGOT TO ADD ANTI-D BLEND THUS GETTING A NEGATIVE RESULT. EVEN THOUGH THE RESULT WAS NEGATIVE AND THE IH-READER 24 INTERPRETED THE RESULT AS "D NEGATIVE," THE SYSTEM MARKED THE QC AS BEING PASSED. THE CUSTOMER HAD TO CHANGE THE "RH D WEAK" TO "RH D POSITIVE" FOR THE SYSTEM TO INTERPRET THE WEAK D QC CORRECTLY. THE QC SETTINGS ON THE PROVIDED PRINT SCREENS WERE CORRECT. PRINT SCREENS PICTURES AND SUPPORT BACKUP DO NOT ALLOW TO CONFIRM THESE SETTINGS AS BEING THE ONE CONFIGURED NOW OF QC SAMPLE PROCESSING DUE TO NO DATE AND TIME ON THE PRINT SCREEN PICTURES. FURTHERMORE, THE SUPPORT BACKUP (PROVIDED FROM OCTOBER 30TH) WAS TAKEN MORE THAN 7 DAYS AFTER THE ISSUE HAS OCCURRED (SEPTEMBER 15TH). THEREFORE, ONLY TRUNCATED LOG DATA WERE AVAILABLE. WE COULD CONFIRM THAT THE RHD WEAK INTERPRETATION IS NOT PROPERLY COMPARED TO THE RHD RESULT INTERPRETATION WHEN NO "REQUIRED REACTIONS" ARE SET WHEN USING THE CURRENT VALIDATED IH-COM VERSION V5.0.9 OR V5.0.10. HOWEVER, THIS ISSUE IS BEING SOLVED WITHIN THE INTRODUCTION OF THE UPCOMING IH-COM VERSION. THE ADVICE FOR THE USER FOR A WORKAROUND, UNTIL THE NEW IH-COM VERSION BECAME AVAILABLE, WAS TO USE THE "REQUIRED REACTION" SETTING FOR "RHD WEAK" SAMPLE IN THE "CONTROL TEST" SECTION SO THAT ONLY THE ACCEPTABLE WELL REACTIONS DO ALLOW TO OBTAIN A VALID QC STATUS. IF ONLY THE TEST SPECIFIC TARGET REACTION STRENGTHS +/-, +, ++, +++ UND ++++ ARE SELECTED THE QC WILL BE GRADED AS FAILED IN CASE OF A NEGATIVE REACTION. FOR FURTHER INFORMATION THE CUSTOMER WAS ADVISED TO CONSULATE THE IH-COM USER MANUAL UNDER THE SECTION "QUALITY CONTROL". THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). THE ROOT CAUSE OF THE COMPLAINT ISSUE WAS IDENTIFIED AS A BUG IN THE SOFTWARE IH-COM V5.0 AND ADDRESSED. THE BUG WAS SOLVED IN THE SOFTWARE VERSION IH-COM V5.2.5. THE SOFTWARE IH-COM V5.2.5 WAS RELEASED ON MARCH 15, 2021.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WEAK D POSITIVE CONTROL WAS INTERPRETED AS D NEGATIVE BY THE IH-READER 24 WITH IH-INTERNAL QC, LOT 51986200093 USED AS CONTROL. WHEN THE CUSTOMER SCANNED SAMPLE 4 FROM THE IH-INTERNAL QC KIT FOR THE WEAK D CONTROL SAMPLE INTO "CONTROL SAMPLE", THE RH TYPING WAS POPULATED WITH A "RH D WEAK" AS RESULT. WHEN SAMPLE 4 WAS RUN FOR THE WEAK D POSITIVE CONTROL, THE TECH FORGOT TO ADD ANTI-D BLEND THUS GETTING A NEGATIVE RESULT. EVEN THOUGH THE RESULT WAS NEGATIVE AND THE IH-READER 24 INTERPRETED THE RESULT AS "D NEGATIVE," THE SYSTEM MARKED THE QC AS BEING PASSED. TESTING OF THE AFFECTED IH-INTERNAL QC IN OUR QUALITY LABORATORY IS STILL ONGOING. INVESTIGATION OF THE AFFECTED IH-READER 24 IS ALSO STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174932 IH-COM V5.0 IH-COM V5.0 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 814172100 51986200093 07611969952342

    Patients

    Seq Age Sex Outcome Treatment
    1 IH READER 24, # 146011005| IH READER 24, # 146011005| IH-INTERNAL QC, LOT 780200093| IH READER 24, # 146011005