BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 12048736 · Received June 23, 2021

    Report

    Report Number
    9610824-2021-00045
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 6, 2021
    Report Date
    August 17, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV A1, B WHEN USED ON IH-1000. THE CUSTOMER STATED THAT THE PATIENT HAS A HISTORY OF BEING BLOOD GROUP O RH(D) POSITIVE WITH WEAKLY EXPRESSED BACK TYPE AND A POSITIVE ANTIBODY SCREENING TEST. THE CUSTOMER PROVIDED THE IMAGE OF THE TEST RESULTS. THE IMAGE SHOWED A DOUBLE POPULATION (DP) RESULT IN THE ANTI-B WELL. THE RESULT WAS ALSO CALLED DP BY THE INSTRUMENT. THE SAMPLE WAS RUN AGAIN ON THE CUSTOMER'S SECOND INSTRUMENT, AND IN TUBE AND THE ERROR COULD NOT BE REPLICATED. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING, BUT THE PATIENT SAMPLE (ONLY RED BLOOD CELLS). OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE ON THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND RECEIVED A CORRECT RESULT. BECAUSE THE CUSTOMER HAD ONLY PROVIDED RED BLOOD CELLS, THE REVERSE TYPING COULD NOT BE PERFORMED. ADDITIONALLY, THE RETENTION SAMPLE WAS TESTED WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE RETENTION SAMPLE WAS ALSO VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF A SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. BASED ON THE IMAGE PROVIDED BY THE CUSTOMER THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UNEXPECTED PRODUCT PERFORMANCE. THE CHECK OF THE DISTRIBUTION SEQUENCES SHOWED THAT THE ANTI-D WELL WAS DISPENSED BEFORE THE ANTI-B WELL. THEREFORE, AN INTER-WELL CONTAMINATION WAS SUSPECTED TO HAVE CAUSED THE FALSE POSITIVE REACTION IN THE ANTI-B. THE FOLLOWING RECOMMENDATION WERE ALREADY ADDRESSED TO THE CUSTOMER AND THE FSE (FIELD SERVICE ENGINEER): CONTROL VISUALLY THE IH CARD BEFORE LOADING, NO SPLASHES UNDER THE ALUMINUM FOIL OR INSIDE THE INCUBATION CHAMBER. REPLACE THE NEEDLE IF IT WAS BENT OR DAMAGED THE ADJUSTMENT OF THE NEEDLE CENTERING RELATIVELY TO THE IH CARD WELLS MUST BE PERFORMED FOR ALL POSITION IN THE PIPETTING AREA. CONTROL AND ADJUST THE DIAMETER OF THE HOLE PIERCED IH CARD. IT MUST BE CENTERED AND CHECKED BY THE DIAMETER TOOLS. CHECK THE IH-CARD PIN PIERCER, REPLACE IT IF IT WAS DAMAGED OR PRESENTS SOME SMUDGE IN THE SURFACE. THE COMPLAINT SAMPLE WAS NOT AVAILABLE, AND THE RETENTION SAMPLE REACTED AS EXPECTED. ALSO, THE PATIENT SAMPLE SHOWED THE EXPECTED RESULT IN THE FORWARD TESTING. IN THE CASE SUMMARY REPORT, IT WAS NOTED THAT THE PATIENT IS KNOWN TO HAVE ONLY WEAKLY EXPRESSED ISOAGGLUTININS, SO THE CUSTOMER SEEMED TO BE PLEASED WITH THAT AND DID NOT COMPLAIN ABOUT IT. THE ISSUE OF FALSE POSITIVE REACTIONS HAS ALREADY BEEN ADDRESSED IN THE CAPA 001-20. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INTIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV A1, B WHEN USED ON IH-1000. THE CUSTOMER STATED THAT THE PATIENT HAS A HISTORY OF BEING BLOOD GROUP O RH(D) POSITIVE WITH WEAKLY EXPRESSED BACK TYPE AND A POSITIVE ANTIBODY SCREENING TEST. NO OTHER OCCURRENCES OF THIS ERROR HAVE BEEN REPORTED. THE CUSTOMER PROVIDED THE IMAGE OF THE TEST RESULTS. THE IMAGE SHOWED A DOUBLE POPULATION (DP) RESULT IN THE ANTI-B WELL. THE RESULT WAS ALSO CALLED DP BY THE INSTRUMENT. THE SAMPLE WAS RERUN ON THE CUSTOMER'S SECOND INSTRUMENT, AND IN TUBE AND THE ERROR COULD NOT BE REPLICATED. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE, BUT THE PATIENT SAMPLE (RED BLOOD CELLS). THE INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING AND ALSO ONGOING IS THE INVESTIGATION OF THE AFFECTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945416 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9103010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, SN 5100042| IH-1000, SN 5100042