BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS

    MDR report key: 5116112 · Received October 1, 2015

    Report

    Report Number
    9610824-2015-00039
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 3, 2015
    Report Date
    December 8, 2015
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CELL #11 OF BIOTESTCELL-I11 PLUS YIELDED A NEGATIVE REACTION WHEN USED WITH MONOCLONAL ANTI-JK(B) REAGENTS WHEN IT IS DECLARED TO BE POSITIVE FOR JK(B) BLOOD GROUP ANTIGEN. THE CUSTOMER USED MONOCLONAL ANTI-JK(B) REAGENTS OF BIO-RAD FOR THE TEST AS WELL AS A COMPETITOR'S TEST REAGENT AND RECEIVED NEGATIVE RESULTS. THE CUSTOMER ALSO USED A POLYCLONAL ANTI-JK(B) REAGENT FOR TESTING AND RECEIVED A WEAK POSITIVE REACTION. THE CUSTOMER DID NEITHER RETURN THE ALLEGEDLY DEFECTIVE BIOTESTCELL-I11 PLUS SAMPLE NOR THE REAGENTS USED IN THIS TEST. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 PLUS WITH SERACLONE ANTI-JK(B) AND COULD CONFIRM THE CUSTOMER'S RESULT. DURING IN-PROCESS CONTROL TESTING THE DONOR OF BIOTESTCELL-I11 PLUS HAD YIELDED A CLEARLY POSITIVE TEST RESULT WITH TWO DIFFERENT ANTI-JK(B) REAGENTS. A SAMPLE OF THE DONOR OF CELL #11 OF BIOTESTCELL-I11 PLUS WAS SENT FOR MOLECULAR TYPING OF THE JK(B) ANTIGEN TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CELL #11 OF BIOTESTCELL-I11 PLUS YIELDED A NEGATIVE REACTION WHEN USED WITH MONOCLONAL ANTI-JK(B) REAGENTS BUT IS DECLARED TO BE POSITIVE FOR JK(B) BLOOD GROUP ANTIGEN. THE CUSTOMER USED MONOCLONAL ANTI-JK(B) REAGENTS OF BIO-RAD FOR THE TEST AS WELL AS A COMPETITOR'S TEST REAGENT AND RECEIVED NEGATIVE RESULTS. THE CUSTOMER ALSO USED A POLYCLONAL ANTI-JK(B) REAGENT FOR TESTING AND RECEIVED A WEAK POSITIVE REACTION. THE CUSTOMER DID NEITHER RETURN THE ALLEGEDLY DEFECTIVE BIOTESTCELL-I11 PLUS SAMPLE NOR THE REAGENTS USED IN THIS TEST. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 PLUS WITH SERACLONE ANTI-JK(B) AND COULD CONFIRM THE CUSTOMER'S RESULT. DURING IN-PROCESS CONTROL TESTING THE DONOR OF BIOTESTCELL-I11 PLUS HAD YIELDED A CLEARLY POSITIVE TEST RESULT WITH TWO DIFFERENT ANTI-JK(B) REAGENTS. A SAMPLE OF THE DONOR OF CELL #11 OF BIOTESTCELL-I11 PLUS WAS SENT FOR MOLECULAR TYPING OF THE JK(B) ANTIGEN TO AN EXTERNAL LABORATORY. MOLECULAR GENETIC TYPING CONFIRMED THAT THIS DONOR IS INDEED JK(A+B+). THERE IS A REFERENCE IN OUR INSTRUCTION FOR USE: BECAUSE SOME ANTIBODIES SHOW DOSAGE EFFECT, THE ANTIGEN DENSITY ON THE REAGENT RED BLOOD CELLS NEEDS TO BE CONSIDERED WHEN EVALUATING THE TEST RESULTS (HOMOZYGOUS OR HETEROZYGOUS HEREDITARY DISPOSITION). A HETEROZYGOUS EXPRESSION OF THE ANTIGEN MAY RESULT IN NON-DETECTION OF WEAK ANTIBODIES DEPENDING ON THE USED TEST METHOD. THE REACTIVITY OF THE PRODUCT MAY DECREASE DURING THE DATING PERIOD AND THEREFORE SHOULD NOT BE USED AFTER THE EXPIRATION DATE. THE RATE OF DECREASE IN REACTIVITY IS PARTIALLY DEPENDANT ON INDIVIDUAL DONOR CHARACTERISTICS THAT ARE NEITHER CONTROLLED NOR PREDICTED BY THE MANUFACTURER. NONETHELESS, THIS DONOR WILL BE EXCLUDED FROM FURTHER DONATIONS. 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
    648231 REAGENT RED BLOOD CELLS BIOTESTCELL-I 11 PLUS BIOTESTCELL-I 11 PLUS KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8533011-00

    Patients

    Seq Age Sex Outcome Treatment
    1