BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15218278 · Received August 12, 2022

    Report

    Report Number
    9610824-2022-00052
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 9, 2022
    Report Date
    October 6, 2022
    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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL 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 QUESTION MARK RESULTS WITH ANTI-D AND ONE FALSE POSITIVE REACTION RESPECTIVELY WITH ANTI-A AND THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON IH-1000. THE CUSTOMER DESCRIBED THE ISSUE AS ONGOING BETWEEN MAY 09 AND (B)(6) 2022. BECAUSE ONLY ONE FALSE POSITIVE REACTION WAS YIELDED, WE REFRAIN FROM SUBMITTING IDENTICAL MDR REPORTS FOR ALL DAYS BETWEEN (B)(6) 2022 TO (B)(6) 2022. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED THE QUESTION MARKS RESPECTIVELY FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION NOR QUESTION MARK RESULTS.A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AN INVESTIGATION OF THE INSTRUMENT WAS NOT YET POSSIBLE, BECAUSE WE ARE STILL WAITING FOR THE REQUESTED TRACE FILES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED QUESTION MARK RESULTS WITH ANTI-D AND ONE FALSE POSITIVE REACTION RESPECTIVELY WITH ANTI-A AND THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV. A1, B ON THE IH-1000 INSTRUMENT. THE CUSTOMER DESCRIBED THE ISSUE AS ONGOING BETWEEN MAY 09 AND JULY 12, 2022. BECAUSE ONLY ONE FALSE POSITIVE REACTION WAS YIELDED, WE REFRAIN FROM SUBMITTING IDENTICAL MDR REPORTS FOR ALL DAYS BETWEEN MAY 09 TO JULY 12, 2022. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE QUESTION MARK RESPECTIVELY FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. IN TOTAL WE TESTED 60 IH-CARDS OF THE SUPPOSEDLY DEFECTIVE LOT. THE FOLLOWING BLOOD GROUPS WERE COVERED: A1, A2, B, A1B, O, RHD POSITIVE, RHD NEGATIVE AND IH-BASIC QC1 (RHD NEGATIVE). THE RED BLOOD CELLS WERE EACH USED IN MULTIPLE DETERMINATIONS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION NOR QUESTION MARK RESULTS. .A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED INSTRUMENT, THE DATA FILES WERE ANALYZED. ACCORDING TO THIS ANALYSIS, THE "?" INTERPRETATION WITH THE ANTI-D IS JUSTIFIED AND IT'S DUE TO THE HIGH TEXTURE IDENTIFIED ON THE WELLS. REGARDING THE "1+" INTERPRETATION ON THE ANI-A AND ANIT-B WELLS, A FIELD SERVICE ENGINEER CHECKED THE CAMERA AND READING MODULE AND PERFORMED ADJUSTMENTS PER MANUAL. HE CLEANED THE BACKLIGHT AND RAN SUCCESSFULLY A CARD CALIBRATION. HOWEVER, THE SECTION INTERPRETATION OF RESULTS OF THE INSTRUCTION FOR USE CONTAINED THE FOLLOWING NOTE:" A VERY WEAK REACTION IS NOT AN EXPECTED RESULT FOR ANTIGEN TESTING. IT MAY INDICATE THAT A FALSE POSITIVE OR A VERY WEAK/PARTIAL EXPRESSION OF THE ANTIGEN IS PRESENT. FURTHER INVESTIGATION OF THIS SAMPLE SHOULD BE PERFORMED BEFORE THE ANTIGEN STATUS IS DETERMINED." THE OBSERVED AND CONFIRMED ISSUE REGARDING THE REACTIONS IN QUESTION IN THE ANTID WAS ALREADY ADDRESSED AND DOCUMENTED AS INTERNAL QUALITY NOFITIFACTION (B)(4). THE FALSE POSITIVE REACTIONS IN THE ANTI-A AND ANTI-B WELLS WERE FORWARDED TO THE RESEARCH AND DEVELOPMENT (R&D) DEPARTMENT FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819613 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 9204010 07611969964529

    Patients

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