BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 11753731 · Received April 30, 2021

    Report

    Report Number
    9610824-2021-00026
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969951147
    PMA / PMN Number
    125094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 SHOWED A FALSE NEGATIVE RH(D) RESULT WHEN THE SAMPLE WAS TESTED USING ERYTYPE S ABD+REV A1,B ON TANGO INFINITY. THE PATIENT HAD BEEN TESTED RH(D) POSITIVE ON TANGO OPTIMO THE PREVIOUS YEAR. THE RH(D) POSITIVE RESULT WAS NOW CONFIRMED BY ANOTHER LABORATORY. THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE ERYTYPE S ABD+REV.A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. REGARDING THE AFFECTED TANGO INFINITY: THE CUSTOMER PROVIDED A BLACK/WHITE RESULT IMAGE OF POOR QUALITY THAT SHOWS A NEGATIVE REACTION FOR BOTH ANTI-D WELLS. THE LAST PREVENTATIVE MAINTENANCE DATE WAS ON (B)(6) 2021 AND THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT. THE QC WAS RUN AND PASSED ALL REQUIREMENTS. DUE TO THE MISSING SAMPLES, THE NEGATIVE RESULTS AT CUSTOMER´S SITE REMAINED UNKNOWN. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BASED ON CURRENT INFORMATION AND DATA THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION. THE QC PASSED AT THE DAYS OF ISSUE. THE RESULT WAS NEGATIVE FOR RH(D) IN BOTH WELLS AND ON BOTH DAYS OF TESTING. THE ONE AVAILABLE RESULT IMAGE SHOWS NORMAL NEGATIVE REACTIONS. THE REPORTED PROBLEM IS LIKELY RELATED TO SAMPLE SPECIFICITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653439 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8950190 07611969951147

    Patients

    Seq Age Sex Outcome Treatment
    1