BEUDAMED
    FDA Adverse Event Death Summary report: N

    TANGO INFINITY

    MDR report key: 5899599 · Received August 24, 2016

    Report

    Report Number
    9610824-2016-00048
    Event Type
    Death
    Date Received
    August 24, 2016
    Date of Event
    July 27, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969961719
    PMA / PMN Number
    BK150327/0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 (B)(6) ANTIBODY SCREENING TESTS OF A PATIENT SAMPLE WHEN TESTED WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II ON TANGO INFINITY. IN A QC RUN TWO HOURS PRIOR TO THE (B)(6) TEST RESULT , THE VERY SAME AHG BOTTLE THAT LATER YIELDED THE (B)(6) TEST RESULT WAS STILL WORKING CORRECTLY AND YIELDED A (B)(6) RESULT. A REGULAR QUALITY CONTROL RUN ON THE INSTRUMENT THE NEXT DAY (22 HOURS AFTER THE (B)(6) ABS) FAILED. WHEN THE AHG BOTTLE WAS REPLACED, THE QC RUN ON THIS INSTRUMENT PASSED. RE-TESTING OF THE PATIENT SAMPLE SHOWED THAT THE SAMPLE WAS PREVIOUSLY REPORTED TO BE (B)(6) BUT FOUND TO BE (B)(6). THE PATIENT WAS A SICKLE CELL PATIENT WITH A HISTORY OF ANTI-C, ANTI-K, ANTI-KP(A), ANTI-JK(B), ANTI-S AND ANTI-SD(A). IN ADDITION TO ALL AFFECTED REAGENTS, THE TANGO INFINITY WAS THOROUGHLY INSPECTED AND ITS PROCESS DATA ANALYZED. ANALYSIS OF THE CONTROLS ARCHIVE DATA SHOWED THAT THE BIO-RAD SOLIDSCREEN II CONTROL WAS NOT USED AS QC BUT AN IN-HOUSE SAMPLE WITH A (B)(6) ABS RESULT PREPARED FROM IMMUCOR ANTI-D MONOCLONAL BLEND. IF THE BEHAVIOR OF THE MATERIAL USED FOR A CONTROL IS WELL KNOWN AND CAN BE REGARDED AS RELIABLE THIS IS AN ACCEPTABLE PROCEDURE. HOWEVER, THE CONTROL RESULTS IN THE LOG-FILE OF THE CONCERNED INSTRUMENT ARE CONSPICUOUS SINCE THEY FAILED A LOT FROM (B)(6) AND EVEN THE VALID RESULTS VARIED A LOT FROM DAY TO DAY (B)(6). THIS USUALLY INDICATES THAT THE INSTRUMENT OR THE ABS ASSAY RESPECTIVELY MAY HAVE NOT BEEN FUNCTIONING PROPERLY. THIS SHOULD HAVE BEEN RECOGNIZED AS SUSPICIOUS LATEST ON (B)(6) WHEN THE REACTION STRENGTH WAS MUCH TOO LOW AND THE CONTROL RESULT MODIFIED MANUALLY. THESE FAILED CONTROLS SHOULD HAVE RESULTED IN A REQUEST FOR A BIO-RAD SERVICE ENGINEER TO LOOK FOR A ROOT CAUSE. IT SEEMS, HOWEVER, THAT THIS HAD NOT BEEN RECOGNIZED BY THE OPERATOR BEFORE (B)(6) WHEN THE (B)(6) PATIENT RESULT WAS GENERATED. ACCORDING TO THE DATA ANALYSIS AND THE INFORMATION PROVIDED BY THE CUSTOMER AND THE U.S. ORGANIZATION NO REAL CAUSE FOR THE UNUSUAL BEHAVIOR AND THE (B)(6) RESULTS HAS BEEN FOUND. HOWEVER, WE CANNOT EXCLUDE ANY PARTICIPATION OF THE INSTRUMENT EITHER. THEREFORE, WE WANT TO INVESTIGATE THE INSTRUMENT IN DETAIL AS SOON AS IT HAS BEEN SHIPPED BACK FROM THE CUSTOMER TO OUR PREMISES IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING RESULTS OF PATIENT SAMPLES WHEN TESTED WITH ANTIHUMAN-GLOBULIN (AHG), ANTI-IGG SOLID SCREEN II (SSC II) ON TANGO INFINITY. ON (B)(6) 2016 AT 10 PM THE SSC II QUALITY CONTROL (QC) RUN FAILED SEVERAL TIMES. ONLY EXCHANGING THE AHG VIAL WITH A FRESH ONE RESOLVED THE ISSUE AND THE QC PASSED. THE CUSTOMER RE-TESTED ALL PATIENT SAMPLES RUN BEFORE THE FAILED QC ON ANOTHER TANGO INFINITY INSTRUMENT (B)(4). THREE OF THEM, WHICH PREVIOUSLY YIELDED FALSE NEGATIVE RESULTS, WERE DETERMINED AS CORRECT POSITIVES. ONE PATIENT RECEIVED 2 INCOMPATIBLE UNITS OF 0 POSITIVE PACKED RED BLOOD CELLS (PRBCS) DUE TO THE FALSE NEGATIVE ANTIBODY DETERMINATION AND USE OF ELECTRONIC CROSSMATCH. THIS PATIENT WAS A SICKLE CELL PATIENT WITH A HISTORY OF ANTI-C, ANTI-K, ANTIKP(A), ANTI-JK(B), ANTI-S AND ANTI-SD(A) AND A HGB OF 1.9 G/DL. THE PATIENT DEMISED ON 07/28/16. A TRANSFUSION REACTION WAS NOT REPORTED TO BMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551791 TANGO INFINITY AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 07611969961719

    Patients

    Seq Age Sex Outcome Treatment
    1 Death