BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 8481602 · Received April 4, 2019

    Report

    Report Number
    9610824-2019-00010
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 4, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WAS TYPED AS O RH(D) NEGATIVE WITH ERYTYPE S ABD+REV.A1, B ON TANGO INFINITY. THE PATIENT WAS KNOWN TO BE O RH(D) POSITIVE. THE CUSTOMER CONFIRMED THE RESULT O RH(D) POSITIVE IN THE MANUAL TUBE TEST. THE CUSTOMER STATED THAT THE PATIENT WAS TYPED AS O RH(D) POSITIVE IN (B)(6) 2019. BEGINNING MARCH THE PATIENT RECEIVED THREE UNITS OF BLOOD GROUP O RH(D) NEGATIVE ON THREE CONSECUTIVE DAYS. AFTERWARDS A PATIENT SAMPLE WAS RUN TWICE ON TANGO INFINITY AND TYPED AS O RH(D) NEGATIVE. THE CUSTOMER RETURNED TWO SAMPLES LABELLED AS (B)(6) FOR INVESTIGATIONAL TESTING, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYPE S ABD+REV.A1,B. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1, B WITH THE PATIENT SAMPLES PROVIDED BY THE CUSTOMER ON TANGO INFINITY. BOTH SAMPLES YIELDED CORRECT POSITIVE RESULTS WITH BOTH ANTI-D REAGENTS (CLONE BS226 AND CLONE BS232) OF THE ERYTYPE PLATE. ADDITIONALLY THE RETENTION SAMPLE OF ERYTYPE S ABD+REV. A1, B WAS TESTED WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO INFINITY: THE CUSTOMER PROVIDED RESULT IMAGES THAT CONFIRM THE NEGATIVE RESULTS FOR THE RH D TYPE IN SAMPLE ID (B)(6) EVALUATED BY INSTRUMENTS RESULT INTERPRETATION SOFTWARE AS WELL AS VISUALLY. THOROUGH INSPECTION REVEALS SMALL AGGLUTINATES WITHIN CELL SUSPENSION IN BOTH ANTI-D WELLS (MIXED FIELD REACTION); SEEN FROM BOTH INSTRUMENTS. THESE SMALL AGGLUTINATES WERE NOT ENOUGH TO CAUSE A POSITIVE RESULT, BECAUSE THE MOST OF THE WELL CONTENT WAS A CELL SUSPENSION AND THE INSTRUMENT DID CORRECT INTERPRETATION TO A NEGATIVE RESULT. THE CUSTOMER PROVIDED ALSO RESULT IMAGE FROM ANOTHER SAMPLE (ID (B)(6)). THIS SAMPLE SHOWS A STRONG POSITIVE RESULT FOR BOTH ANTI-D CLONES AS EXPECTED. LAST SEMI-ANNUAL PREVENTIVE MAINTENANCE ON THE INSTRUMENT WAS PERFORMED AS PER CHECKLIST ON 03/13/19. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATION. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. THE REPORTED PROBLEM IS LIKELY RELATED TO SAMPLE SPECIFICITIES, BECAUSE WE ASSUME A MIXED FIELD DUE TO THE TRANSFUSION ON THREE CONSECUTIVE DAYS BEFORE SAMPLE WAS DRAWN. MIXED FILED REACTION CAN LEAD TO ERRONEOUS RESULT AS STATED IN DIFFERENT SECTIONS OF THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274704 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8823210

    Patients

    Seq Age Sex Outcome Treatment
    1