BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8747931 · Received July 1, 2019

    Report

    Report Number
    9610824-2019-00028
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 3, 2019
    Report Date
    January 26, 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
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RHD DISCREPANT RESULTS OF ONE PATIENT SAMPLE WITH IH-CARD ABO/D(DVI-) +REV.A1, B ON IH-1000. THE CUSTOMER TESTED THIS PATIENT THREE TIMES ON THREE DIFFERENT DATES ON ONE IH-1000. ON (B)(6) 2019 THE PATIENT SAMPLE WAS TESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8844060 ON IH-1000. THE RESULT WITH THE ANTI-D (DVI-) WAS 2+ POSITIVE AND INTERPRETED AS POSITIVE BY THE INSTRUMENT. ON (B)(6) 2019 THE PATIENT SAMPLE WAS TESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8850080 ON IH-1000. THE RESULT WITH THE ANTI-D (DVI-) WAS 1+ POSITIVE AND INTERPRETED AS NEGATIVE BY THE INSTRUMENT. THE INSTRUMENT DID FLAG THIS RESULT DUE TO THE DISCREPANCY. ON (B)(6) 2019 THE PATIENT SAMPLE WAS RE-TESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8850080 ON IH-1000. THE RESULT WITH THE ANTI-D WAS ? (QUESTION MARK) THAT WAS VISUALLY INTERPRETED AS NEGATIVE. ADDITIONALLY, THE CUSTOMER REPORTED THAT SHE USED THE SAME PATIENT SAMPLE FOR THE TESTING ON (B)(6) 2019 . BOTH PATIENT SAMPLES WERE ALSO TESTED MANUALLY AND YIELDED NEGATIVE RESULTS IN THE IMMEDIATE SPIN TUBE TEST BUT 2+ POSITIVE RESULTS IN THE WEAK D TESTING WITH ANTI-HUMAN GLOBULIN (AHG). THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT THE PATIENT SAMPLE THAT HAD CAUSED DISCREPANT RESULTS. THEREFORE,OUR QUALITY CONTROL (QC) LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETENTION SAMPLES OF BOTH LOTS USED BY CUSTOMER ON IH-1000. THE PATIENT SAMPLE GAVE A 1+ POSITIVE REACTION ON IH-CARD ABO/D(DVI-)+REV. A1, B LOT #8844060 AND LOT #8850080. ADDITIONALLY, BOTH LOTS WERE TESTED WITH DIFFERENT DONOR SAMPLES, INCLUDING WEAK D SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE PATIENT SAMPLE WAS ALSO TESTED WITH IH-ANTI-D BLEND ON IH-1000 AND GAVE A 3+ POSITIVE REACTION. THE AFFECTED PATIENT SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR MOLECULAR GENETIC ANALYSIS WITH THE FOLLOWING RESULTS: CCD.EE WEAK D TYPE 2 (ISBT: RHD*01W.2) WHICH IS THE EXPLANATION FOR THE WEAK REACTION PATTERN WITH THE ANTI-D (DVI-). THE POSSIBLE REACTION OF SAMPLES WITH WEAKENED D ANTIGENS IS DESCRIBED IN THE INSTRUCTION FOR USE OF IH-CARD ABO/D(DVI-)+REV.A1, B. THE SECTION "INTERPRETATION OF RESULTS" CONTAINS THE FOLLOWING NOTE: "POSITIVE* (+/- AND +), *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. AND THE SECTION "LIMITATIONS" CONTAINS THE FOLLOWING NOTE: "VERY WEAK EXPRESSIONS OF THE D ANTIGEN MAY NOT BE DETECTED. THE DVI EPITOPE OF THE D ANTIGEN WILL NOT BE DETECTED WITH THIS REAGENT. NO BLOOD GROUPING REAGENT OF MONOCLONAL ORIGIN HAS YET BEEN FOUND THAT WILL DETECT ALL PARTS OF THE D ANTIGEN. IF THE DETECTION OF WEAK D AND PARTIAL D(VI) SAMPLES IS REQUIRED, THE SAMPLES PRODUCING NEGATIVE RESULTS WITH THIS ANTI-D REAGENT SHOULD BE FURTHER TESTED WITH AN ANTI-D REAGENT KNOWN TO DETECT WEAK D ANTIGEN EXPRESSION (I.E. IH-ANTI-D (RH1) BLEND)." TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT 8850080 OF IH-CARD ABO/D (DVI-)+REV.A1, B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INSTRUCTION FOR USE ALREADY CONTAINS APPROPRIATE NOTES AND AS THE WEAK REACTIONS WERE SAMPLE RELATED.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RH D DISCREPANT RESULTS OF ONE PATIENT WITH IH-CARD ABO/D(DVI-) +REV.A1, B ON IH-1000. THE CUSTOMER TESTED A PATIENT THREE TIMES ON THREE DIFFERENT DATES ON ONE IH-1000 ((B)(4)). ON (B)(6) 2019 A PATIENT SAMPLE WAS TESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8844060 ON IH-1000. THE RESULT WITH THE ANTI-D (DVI-) WAS 2+ POSITIVE AND INTERPRETED AS POSITIVE BY THE INSTRUMENT. ON (B)(6), 2019 A PATIENT SAMPLE WAS TESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8850080 ON IH-1000. THE RESULT WITH THE ANTI-D (DVI-) WAS 1+ POSITIVE AND INTERPRETED AS NEGATIVE BY THE INSTRUMENT. THE INSTRUMENT DID FLAG DUE TO THE DISCREPANT RESULT. ON JUNE 03, 2019 THE PATIENT SAMPLE WAS RETESTED WITH IH-CARD ABO/D(DVI-)+REV.A1, B LOT 8850080 ON IH-1000. THE RESULT WITH THE ANTI-D WAS ? (QUESTION MARK) THAT WAS VISUALLY INTERPRETED AS NEGATIVE. THE CUSTOMER REPORTED THAT SHE USED THE SAME PATIENT SAMPLE FOR THE TESTING ON (B)(6) 2019 AND (B)(6) 2016. ADDITIONALLY THE CUSTOMER TESTED BOTH PATIENT SAMPLES MANUALLY. BOTH SAMPLES YIELDED NEGATIVE RESULTS IN THE IMMEDIATE SPIN TUBE TEST BUT 2+ POSITIVE RESULTS IN THE WEAK D TESTING WITH ANTI-HUMAN GLOBULIN (AHG). THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATINAL TESTING BUT ONE PATIENT SAMPLE THAT HAD CAUSED DISCREPANT RESULTS. TESTING IN OUR QUALITY CONTROL LABORATORY AND AN EXTERNAL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545092 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 8850080 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000| IH-1000| IH-CARD ABO/D(DVI-)+REV.A1, B, LOT 8844060| IH-CARD ABO/D(DVI-),..., LOT 8844060