BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-D BLEND

    MDR report key: 8953426 · Received September 2, 2019

    Report

    Report Number
    9610824-2019-00048
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Date of Event
    August 5, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969950201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT RH(D) TYPING RESULT COMPARED TO THE TEST RESULT WHEN REAGENTS OF COMPETITORS WERE USED. THIS SITE REPORTED A RH(D) NEGATIVE RESULT ON A PRE-NATAL PATIENT SAMPLE WITH SERACLONE ANTI-D BLEND (REF #: 802033100, LOT #: 8905130-04). THE PATIENT GAVE BIRTH AND THE HOSPITAL WHERE SHE DELIVERED REPORTED A RH(D) POSITIVE TEST RESULT WHEN USING ORTHO REAGENTS. THE CUSTOMER TOOK ANOTHER PATIENT SAMPLE ABOUT 3 WEEKS AGO AND RETESTED IT: IN THE IMMEDIATE SPIN METHOD THEY YIELDED A +/- REACTION, A 1+ POSITIVE REACTION AFTER INCUBATING 10 MINUTES AT 37°C AND A 4+ POSITIVE REACTION IN THE INDIRECT ANTI-GLOBULIN TEST. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING BUT NOT THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLE AND ALSO A REFERENCE LOT (LOT #: 8922070-04) FOR POTENCY AND SPECIFICITY. ALL REACTIONS WERE CORRECT. THE MINIMUM TITER OF 32 WAS EXCEEDED. AND ALL THREE REAGENTS (COMPLAINT SAMPLE AND RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT AS WELL AS THE RETENTION SAMPLE OF THE REFERENCE LOT) SHOWED COMPARABLE RESULTS. SERACLONE ANTI-D BLEND IS FORMULATED TO OPTIMIZE THE REACTION AT ANTI-HUMAN GLOBULIN (AHG) AND THEREFORE MIGHT GIVE WEAKER REACTIONS AT IMMEDIATE SPIN METHOD. ACCORDING TO THE NOTE IN THE SECTION LIMITATION OF THE INSTRUCTION FOR USE WE RECOMMEND: "IF THE IMMEDIATE REACTION WITH ANTI-D (RH1) BLEND IS NEGATIVE, A TEST FOR WEAK D OR PARTIAL D MAY BE PERFORMED." TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-D BLEND FUNCTIONS CORRECTLY. 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 INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT D TYPING RESULTS COMPARED TO OTHER REAGENTS (ORTHO, IMMUCOR). TESTING OF A PATIENT SAMPLE WITH SERACLONE ANTI-D (RH1) BLEND GAVE +/- RESULT AT IMMEDIATE SPIN, 1+ AFTER INCUBATING 10 MINUTES AT 37 DEGREES, AND WHEN TESTED AT AHG IT GABE 4+ RESULTS. THE SAME SAMPLE GAVE A 3+ RESULT WHEN TESTED IN IMMEDIATE SPIN USING ORTHO ANTI-D BUT YIELDED AN 1+ REACTION IN THE IMMEDIATE SPIN USING IMMUCOR ANTI-D. THE CUSTOMER ANNOUNCED TO SEND THE SUPPOSEDLY DEFECTIVE PRODUCT THAT HAD CAUSED DISCREPANT RESPECTIVELY WEAKENED RESULTS FOR INVESTIGATIONAL TESTING. WE ARE STILL WAITING FOR THIS SAMPLE. 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
    746936 BLOOD GROUPING REAGENT ANTI-D BLEND SERACLONE ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8905130-04 07611969950201

    Patients

    Seq Age Sex Outcome Treatment
    1