BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2223921 · Received April 14, 2011

    Report

    Report Number
    9610824-2011-00041
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSITCS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REAGENTS IN USE HAVE NOT BEEN TAKEN INTO CONSIDERATION TO BE CAUSATIVE SINCE NO OTHER SAMPLE TESTED ON THE DATE OF EVENT SHOWED DISCREPANT RESULTS WHEN TESTED AGAIN. THAT MEANS ALL OTHER RESULTS OBTAINED ON THE DATE OF THE EVENT ARE VALID. THE BLOOD GROUP OF THE SAMPLE IN QUESTION WAS ALSO TESTED CORRECTLY WITHIN TWO CONFIRMATION RUNS ON (B)(6). ALL THE QUALITY CONTROLS PERFORMED ON (B)(6) SHOW NO SIGNS OF PROBLEMS. ACCORDING TO THESE INFORMATIONS IT SEEMS LIKELY THAT THE SAME BARCODE OF THE SAMPLE IN QUESTION WAS USED FOR A SPECIMEN FROM A DIFFERENT INDIVIDUAL. THIS IS SUPPORTED BY THE FACT THAT NOT ONLY ABO BLOOD GROUPS OF THE SAMPLE TESTED ON (B)(6) DIFFERED FROM EACH OTHER BUT ALSO THE RH PHENOTYPE (CCD.EE VS. CCD.EE). A CAPA WAS INITIATED FOR THE DELAY IN REPORTING.

    Description of Event or Problem · 1

    ON (B)(6) 2011 AN O POS PATIENT WAS DETERMINED AS A POS. (B)(6). PATIENT ID ON (B)(6) 2011: (B)(6). TANGO OPTIMO TEST RESULT: A RH POS.CCS.EE, KELL NEG.AKS NEG. PATIENT ID ON (B)(6)2011: (B)(6). TANGO OPTIMO TEST RESULT: 0 RH POS, CCD/EE AKS NEG. CORRECT RESULT ACCORDING TO BLOOD DONOR PASS: 0 RH POS, CCD.EE AKS NEG. A CROSS MIX-UP OF SAMPLE NUMBER AND PATIENT ID IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYZER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSITCS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 ERYTYPE S AB0: (CAT# 806 115), LOT 1018030| EXP: 10/30/2011| BROMELIN: (CAT# 896 220), LOT 1033140| EXP. 02/13/2011