BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 5346245 · Received January 6, 2016

    Report

    Report Number
    9610824-2015-00058
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    December 4, 2015
    Report Date
    February 5, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 A MISMATCH OF RESULTS BETWEEN TWO SAMPLES, NOT REPORTED BY THE INSTRUMENT. ONE SAMPLE WAS TYPED C POSITIVE ON ERYTYPE S RH+K AND THE OTHER SAMPLE WAS TYPED C NEGATIVE. BOTH SAMPLES HAD DIFFERENT SAMPLE NUMBERS, BUT BELONG TO ONE SINGLE PATIENT. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLE THAT HAD CAUSED DISCREPANT RESULTS NOR THE SUPPOSEDLY DEFECTIVE WAS SENT BACK FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY A FIELD SERVICE ENGINEER. THE INSTRUMENT IS WORKING WITHIN ITS SPECIFICATIONS AND ALL QC TESTS WERE PASSED. ADDITIONAL REQUESTED INFORMATION HAS NOT BEEN DELIVERED YET FOR FURTHER INVESTIGATIONS. A FINAL STATEMENT WILL BE GIVEN AS SOON AS WE RECEIVE MORE DETAILS CONCERNING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MISMATCH OF RESULTS BETWEEN TWO SAMPLES, NOT REPORTED BY THE INSTRUMENT. ONE SAMPLE WAS TYPED C POSITIVE ON ERYTYPE S RH+K AND THE OTHER SAMPLE WAS TYPED C NEGATIVE. BOTH SAMPLES HAD DIFFERENT SAMPLE NUMBERS, BUT BELONGED TO ONE SINGLE PATIENT. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLE THAT HAD CAUSED DISCREPANT RESULTS NOR THE SUPPOSEDLY DEFECTIVE WAS SENT BACK FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ERYTYPE S RH+K REAGENT WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY A FIELD SERVICE ENGINEER. THE INSTRUMENT WAS WORKING WITHIN ITS SPECIFICATIONS AND ALL QC TESTS WERE PASSED. THE INSPECTED LOG FILES SHOWED NO IRREGULARITIES. WE HAVE NO INSTIGATION TO SUSPECT THE INSTRUMENT PERFORMANCE TO BE CAUSATIVE FOR THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8447 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1