BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 5483035 · Received March 7, 2016

    Report

    Report Number
    9610824-2016-00009
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 5, 2016
    Report Date
    April 21, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL 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 SAMPLE SHOWED A FALSE POSITIVE REACTION WHEN TESTED WITH ANTI-C ON ERYTYPE S RH+K TYPE ON TANGO OPTIMO. THE CUSTOMER DID RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR FURTHER INVESTIGATION AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY RETESTED THE PATIENT SAMPLE WITH THE PROVIDED SAMPLE OF ERYTYPE S RH+K TYPE AND COULD CONFIRM THE CUSTOMER'S RESULT. THE PATIENT SAMPLE YIELDED A CLEARLY POSITIVE REACTION WITH ANTI-C ON ERYTYPE. THE PATIENT SAMPLE WAS ALSO TESTED IN THE TUBE TECHNIQUE WITH DIFFERENT MONOCLONAL AND POLYCLONAL ANTI-C REAGENTS AND ALSO IN THE GEL METHOD. THE PATIENT SAMPLE SHOWED CLEAR POSITIVE REACTIONS WITH ALL USED REAGENTS. DUE TO THESE TEST RESULTS THE POSITIVE TEST RESULT WITH ERYTYPE SEEMS TO BE A CORRECT POSITIVE RESULT. BECAUSE THE PROVIDED PATIENT SAMPLE WAS A DONOR SEGMENT AND THEREFORE NOT SUITED FOR MOLECULAR TYPING, MOLECULAR TYPING FOR RHESUS C ANTIGEN COULD NOT BE PERFORMED. THE SUPPOSEDLY DEFECTIVE LOT WAS TESTED WITH DIFFERENT SAMPLES. 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 RH+K TYPE 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 PATIENT SAMPLE SHOWED A FALSE POSITIVE REACTION WHEN TESTED WITH ANTI-C ON ERYTYPE S RH+K TYPE ON TANGO OPTIMO. THE CUSTOMER DID RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR FURTHER INVESTIGATION AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140352 ERYTYPE S RH+K TYPE ERYTYPE S RH+K TYPE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8448090

    Patients

    Seq Age Sex Outcome Treatment
    1