BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND

    MDR report key: 11920746 · Received June 2, 2021

    Report

    Report Number
    9610824-2021-00036
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    February 10, 2021
    Report Date
    July 23, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969950201
    PMA / PMN Number
    125223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH SERACLONE ANTI-D BLEND WHEN USED MANUALLY. THE REAGENT OF A COMPETITOR GAVE A NEGATIVE TEST RESULT. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, THE CAP SURVEY SAMPLE J-05R THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS AND THE ANTI-D REAGENT OF THE COMPETITOR (QUOTIENT ALBACLONE ANTI-D BLEND, (B)(6)). OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE AND A REFERENCE LOT FOR POTENCY. ALL THREE REAGENTS MET THE MINIMUM TITER OF 32 AND SHOWED COMPARABLE RESULTS. THE CAP SURVEY SAMPLE WAS TESTED WITH THE COMPLAINT SAMPLE, THE RETENTION SAMPLE, THE REFERENCE LOT AND QUOTIENT ALBACLONE ANTI-D BLEND. FOR THESE TESTS THE CAP SURVEY SAMPLE WAS USED READY FOR USE AND WASHED. THE USED TEST METHODS WERE IMMEDIATE SPIN AND THE INDIRECT ANTIGLOBULIN TEST (IAT, 30 MIN AT 37°C). THE CAP SURVEY SAMPLE SHOWED NEGATIVE RESULTS IN ALL TESTS. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS TESTED WITH IH-ANTI-D BLEND IN THE IH-CARD AHG ANTI-IGG, IN THE IH-CARD DVI+ AND IN THE IH-CARD DVI-. AGAIN, ALL RESULTS WERE CLEARLY NEGATIVE. THE CUSTOMER'S WEAK FALSE POSITIVE RESULTS COULD NOT BE REPRODUCED IN OUR OF THE QUALITY CONTROL LABORATORY. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNJUSTIFIED: THE COMPLAINT SAMPLE AS WELL AS THE RETENTION SAMPLE REACTED AS EXPECTED. THE CAP SURVEY SAMPLE SHOWED CORRECTLY NEGATIVE RESULTS IN ALL TESTS PERFORMED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH SERACLONE ANTI-D BLEND WHEN USED MANUALLY. THE REAGENT OF A COMPETITOR GAVE A NEGATIVE TEST RESULT. THE CUSTOMER SENT IN THE COMPLAINT SAMPLE SERACLONE ANTI-D BLEND FOR INVESTIGATIONAL TESTING, THE CAP SURVEY SAMPLE J-05R THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS AND THE ANTI-D REAGENT OF THE COMPETITOR (QUOTIENT ALBACLONE ANTI-D BLEND, V215859). THE INVESTIGATION OF THE COMPLAINT SAMPLE AS WELL AS OF THE RETENTION SAMPLE IS 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
    817511 BLOOD GROUPING REAGENT ANTI-D (RH1) BLEND SERACLONE® ANTI-D (RH1) BLEND; 10X10ML QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8936080-02 07611969950201

    Patients

    Seq Age Sex Outcome Treatment
    1