BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K REAGENT II

    MDR report key: 2418991 · Received January 18, 2012

    Report

    Report Number
    9610824-2011-00205
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 15, 2011
    Report Date
    January 30, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS TESTED WITH ERYTYPE S RH+K REAGENT II AND REACTED NEGATIVELY WITH ANTI-C ((B)(4)) AND ANTI-E ((B)(4)). THE PATIENT SAMPLE THAT HAD CAUSED NEGATIVE REACTIONS WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. OUR QUALITY CONTROL LABORATORY RETESTED THE PATIENT SAMPLE WITH THE RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT II. TESTING CONFIRMED THE CUSTOMER'S RESULT. FURTHER TESTING OF THE SAMPLE WITH DIFFERENT ANTI-C REAGENTS AND ANTI-E REAGENTS RESULTED IN POSITIVE RESPECTIVELY NEGATIVE RESULTS. THEREFORE THE SAMPLE WAS SENT FOR MOLECULAR RH PHENOTYPING TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT. FURTHERMORE DIFFERENT RED CELLS WERE TESTED WITH THE RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT II. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CUSTOMER'S RESULT REGARDING THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K REAGENT II. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE HAVE NO FURTHER COMPLAINTS RELATED TO THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS TESTED WITH ERYTYPE S RH+K REAGENT II AND REACTED NEGATIVELY WITH ANTI-C (CLONE MS273) AND ANTI-E (CLONE MS260/MS12). THE PATIENT SAMPLE THAT HAD CAUSED NEGATIVE REACTIONS WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. OUR QUALITY CONTROL LABORATORY RETESTED THE PATIENT SAMPLE WITH THE RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT II. TESTING CONFIRMED THE CUSTOMER'S TEST RESULT. FURTHER TESTING OF THE SAMPLE WITH DIFFERENT ANTI-C REAGENTS AND ANTI-E REAGENTS RESULTED IN POSITIVE RESPECTIVELY NEGATIVE RESULTS. THEREFORE, THE SAMPLE WAS SENT FOR MOLECULAR RH PHENOTYPING TO AN EXTERNAL LABORATORY. THESE EXTERNAL TESTS WERE VERY COMPREHENSIVE AND YIELDED IN THE RH PHENOTYPE (C)CD.(E)E, BUT WITH THE HYBRID GENE RHCE-RHD(2,3)-RHCE. THE EXISTENCE OF THE HYBRID GENE GIVES THE EXPLANATION FOR THE SEROLOGICAL FINDINGS AND THE DISCREPANT REACTION PATTERNS WITH DIFFERENT MONOCLONAL REAGENTS ANTI-C AND ANTI-E DEPENDING ON THE CLONES. OUR QUALITY CONTROL LABORATORY ALSO TESTED DIFFERENT RED CELLS WITH THE RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT II. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K REAGENT II FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE HAVE NO FURTHER COMPLAINTS RELATED TO THIS LOT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S RH+K REAGENT II ERYTYPE S RH+K REAGENT II KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2131050

    Patients

    Seq Age Sex Outcome Treatment
    1