BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 3822546 · Received May 21, 2014

    Report

    Report Number
    9610824-2014-00036
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 30, 2014
    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 AN INVALID RESULT OF ONE SAMPLE WHEN TESTING WITH ERYTYPE S ABD+REV A1,B ON TANGO OPTIMO. FORWARD TESTING OF THE SPECIMEN WAS BLOODGROUP AB AND REVERSE TYPING WAS BLOODGROUP A. THAT SAME SPECIMEN WAS RETESTED ON TANGO OPTIMO AND CORRECTLY INTERPRETED AS BLOODGROUP A. THE CUSTOMER DID RETURN THE SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. TESTING OF THE RETAINED ERYTYPE S ABD+REVA1,B SAMPLE IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. 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 AN INVALID RESULT OF ONE SAMPLE WHEN TESTING WITH ERYTYPE S ABD+REV A1,B ON TANGO OPTIMO. FORWARD TESTING OF THE SPECIMEN WAS BLOODGROUP AB AND REVERSE TYPING WAS BLOODGROUP A. THAT SAME SPECIMEN WAS RETESTED ON TANGO OPTIMO AND CORRECTLY INTERPRETED AS BLOODGROUP A. THE CUSTOMER DID RETURN THE 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 PATIENT SAMPLE WITH THE RETAINED SAMPLE OF ERYTYPE S ABD+REV.A1. THE FORWARD TESTING YIELDED THE CORRECT RESULT BLOODGROUP A. THE RETAINED SAMPLE WAS ALSO TESTED WITH DIFFERENT RED BLOOD CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1,B 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
    303794 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8335010

    Patients

    Seq Age Sex Outcome Treatment
    1 BROMELIN, LOT 8347110-00| ERYTYPECELL A1&B, LOT 841201100| ERYTYPECELL A1&B, LOT 841201100| BROMELIN, LOT 8347110-00