BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-D BLEND

    MDR report key: 9081017 · Received September 18, 2019

    Report

    Report Number
    9610824-2019-00051
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 20, 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
    MO, 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 FALSE NEGATIVE RESULTS OF TWO RH(D) POSITIVE SAMPLE WITH SERACLONE ANTI-D BLEND IN THE IMMEDIATE SPIN METHOD. THE CUSTOMER STATED THAT THE RESULT OF ONE RH(D) POSITIVE SAMPLE WAS CORRECTLY POSITIVE AFTER USING TWO DROPS OF SERACLONE ANTI-D BLEND LOT: 8832110-02. AND THE CUSTOMER RECEIVED A CORRECTLY POSITIVE RESULT OF THE SECOND RH(D) POSITIVE SAMPLE AFTER 15 MINUTES INCUBATION USING SERACLONE ANTI-D BLEND LOT: 8905130-04. THE CUSTOMER SITE USUALLY DOES NOT PERFORM THE WEAK D TEST USING THIS REAGENT UNLESS THE SAMPLE IS FROM A NEWBORN. THE CUSTOMER PROVIDED COMPLAINT SAMPLES OF BOTH SERACLONE ANTI-D LOTS (REF#: (B)(4), LOT #: 8832110-02 AND LOT#: 8905130-04) THEY USED AT THE SITE AND TWO SPECIMENS OF ONE PATIENT (BOTH LABELED AS 8/27/2019 0500) THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLES AS WELL AS THEIR RETENTION SAMPLES AND A REFERENCE LOT (LOT#: 8922070-04) FOR POTENCY AND SPECIFICITY. ALL REACTIONS WERE CORRECT. THE MINIMUM TITER OF 32 WAS ALWAYS MET. AND ALL THREE REAGENTS (COMPLAINT SAMPLE AND RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCTS AS WELL AS THE RETENTION SAMPLE OF THE REFERENCE LOT) SHOWED COMPARABLE RESULTS. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH BOTH LOTS OF THE SUPPOSEDLY DEFECTIVE PRODUCT IN THE IMMEDIATE SPIN METHOD. THE REACTIONS WERE NEGATIVE. AFTER AN INCUBATION OF 15 MINUTES AT ROOM TEMPERATURE, WHICH IS NOT ACCORDING TO THE INSTRUCTION FOR USE, THE REACTIONS WERE 2W POSITIVE. IN THE INDIRECT ANTIGLOBULIN TEST (IAT) THE PATIENT SAMPLE WAS 4+ POSITIVE WITH ALL SERACLONE ANTI-D BLEND REAGENTS. THE PATIENT SAMPLE WAS SENT FOR MOLECULAR TYPING TO AN EXTERNAL LABORATORY. THE RESULT WAS CCD.EE WEAK D TYPE 1. SERACLONE ANTI-D BLEND IS FORMULATED TO OPTIMIZE THE REACTION AT ANTI-HUMAN GLOBULIN (AHG) AND THEREFORE MIGHT GIVE WEAKER RESPECTIVELY NEGATIVE REACTIONS WHEN USED IN THE 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 LOTS OF SERACLONE ANTI-D BLEND FUNCTION CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOTS.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO RH(D) POSITIVE KNOWN SAMPLES WITH THE USE OF SERACLONE ANTI-D BLEND (LOT #8832110-02) IN THE IMMEDIATE SPIN TUBE TEST. THE CUSTOMER REPEATED THE TEST OF ONE OF THE RH(D) KNOWN POSITIVE SAMPLE ON THE SAME DAY AND RECEIVED A POSITIVE REACTION OF THIS SAMPLE WHEN USING TWO DROPS OF SERACLONE ANTI-D BLEND LOT 8832110-02. ON AUGUST 22, THE TESTING OF THE SECOND RH(D) POSITIVE KNOWN PATIENT WITH THE USE OF SERACLONE ANTI-D BLEND LOT # 8905130-04 IN THE IMMEDIATE SPIN METHOD YIELDED INTO CORRECTLY POSITIVE RESULTS AFTER A 15 MINUTES INCUBATION OF SERACLONE ANTI-D BLEND. THE CUSTOMER DID RETURN THE SUPPOSEDLY DEFECTIVE PRODUCTS AND TWO PATIENT SPECIMENS FOR INVESTIGATIONAL TESTING. THE TESTING OF OUR QUALITY CONTROL 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 LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879124 BLOOD GROUPING REAGENT ANTI-D BLEND SERACLONE ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8832110-02 07611969950201

    Patients

    Seq Age Sex Outcome Treatment
    1 SERACLONE ANTI-D BLEND #8905130-04| SERACLONE ANTI-D BLEND #8905130-04