BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-A

    MDR report key: 2876909 · Received December 18, 2012

    Report

    Report Number
    9610824-2012-00210
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    June 5, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 A KNOWN (B)(6) PATIENT YIELDED A POSITIVE RESULT WITH SERACLONE ANTI-A. THE CUSTOMER HAS RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF SERACLONE ANTI-A WITH THE PATIENT SAMPLE AND COULD CONFIRM THE CUSTOMER'S WEAK POSITIVE REACTION. THE PATIENT SAMPLE SHOWED A MIXED FIELD REACTION. FURTHER TESTING OF THE SAMPLE ALSO YIELDED IN A POSITIVE REACTION WITH CELL O IN REVERSE TYPING. THESE REVERSE TYPING'S TEST RESULTS DID NOT MATCH THE BLOODGROUP B THE CUSTOMER HAD REPORTED. ADDITIONAL TESTS OF THE SAMPLE WERE NOT POSSIBLE, BECAUSE THE PATIENT MATERIAL WAS EXHAUSTED. WE REQUESTED A NEW PATIENT SAMPLE FROM CUSTOMER´S SITE FOR FURTHER SEROLOGICAL TESTS AND A MOLECULAR TYPING OF THE ABO BLOOD GROUP. THE CUSTOMER INFORMED US THAT IT IS NOT POSSIBLE TO OBTAIN A NEW SAMPLE OF THE PATIENT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-A FUNCTIONS CORRECTLY. 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 · 1

    THE CUSTOMER REPORTED THAT A KNOWN B POSITIVE PATIENT YIELDED A POSITIVE RESULT WITH SERACLONE ANTI-A. THE CUSTOMER HAS RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF SERACLONE ANTI-A WITH THE PATIENT SAMPLE AND COULD CONFIRM THE CUSTOMER'S WEAK POSITIVE REACTION. THE PATIENT SAMPLE SHOWED A MIXED FIELD REACTION. FURTHER TESTING OF THE SAMPLE ALSO YIELDED IN A POSITIVE REACTION WITH CELL O IN REVERSE TYPING. THESE REVERSE TYPING'S TEST RESULTS DID NOT MATCH THE BLOODGROUP B THE CUSTOMER HAD REPORTED. ADDITIONAL TESTS OF THE SAMPLE WERE NOT POSSIBLE, BECAUSE THE PATIENT MATERIAL WAS EXHAUSTED. FOR FURTHER TESTS, INCLUDING A MOLECULAR ABO TYPING, WE WILL REQUEST ANOTHER PATIENT SAMPLE FROM THE CUSTOMER´S SITE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-A FUNCTIONS CORRECTLY. 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
    1 BLOOD GROUPING REAGENT ANTI-A SERACLONE ANTI-A KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8144010-07

    Patients

    Seq Age Sex Outcome Treatment
    1