BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 3251423 · Received July 29, 2013

    Report

    Report Number
    9610824-2013-00072
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 31, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 FALSE POSITIVE REACTIONS CAUSED BY WHAT HE ASSUMED WAS CARRY OVER OF A PATIENT SAMPLE WITH AN ANTI-D AND ANTI-C WHEN TESTING ON TANGO OPTIMO. FIRST FOLLOWING SAMPLE AFTER A KNOWN POSITIVE (ANTI-D, ANTI-C) SAMPLE REACTED POSITIVELY IN CELL 1 AND 2 OF A THREE CELL SCREENING. REPEAT RUN ON SAME INSTRUMENT YIELDS A NEGATIVE SCREEN RESULT THAT WAS CONFIRMED BY THE GEL METHOD. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE REAGENTS WERE PROVED BY TESTING THE RETAINED SAMPLES OF OUR QUALITY CONTROL LABORATORY ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORDS DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE INVOLVED LOTS. TAKEN TOGETHER AND MAINLY BASED ON THE FINDINGS OF THE FIELD SERVICE ENGINEER AS WELL AS ON THE NEGATIVE RESULT OBTAINED FROM THE REPEAT RUN WITH THE SAMPLE IN QUESTION AT THE CUSTOMER SITE, WE HAVE NO INSTIGATION TO SUSPECT INSTRUMENT PERFORMANCE ISSUES TO BE CAUSATIVE FOR THE REPORTED PROBLEM. RETESTING OF THE COMPLAINT SAMPLES AT BMD IS STILL ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS CAUSED BY WHAT HE ASSUMED WAS CARRY OVER OF A PATIENT SAMPLE WITH AN ANTI-D AND ANTI-C WHEN TESTING ON TANGO OPTIMO. FIRST FOLLOWING SAMPLE AFTER A KNOWN POSITIVE (ANTI-D, ANTI-C) SAMPLE REACTED POSITIVELY IN CELL 1 AND 2 OF A THREE CELL SCREENING. REPEAT RUN ON SAME INSTRUMENT YIELDS A NEGATIVE SCREEN RESULT THAT WAS CONFIRMED BY THE GEL METHOD. THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE REAGENTS WERE PROVED BY TESTING THE RETAINED SAMPLES OF OUR QUALITY CONTROL LABORATORY ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORDS DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE INVOLVED LOTS. TAKEN TOGETHER AND MAINLY BASED ON THE FINDINGS OF THE FIELD SERVICE ENGINEER AS WELL AS ON THE NEGATIVE RESULT OBTAINED FROM THE REPEAT RUN WITH THE SAMPLE IN QUESTION AT THE CUSTOMER SITE, WE HAVE NO INSTIGATION TO SUSPECT INSTRUMENT PERFORMANCE ISSUES TO BE CAUSATIVE FOR THE REPORTED PROBLEM. WHEN RETESTING OF THE COMPLAINT SAMPLE AT BMD, THE CARRYOVER COULD BE REPRODUCED WITH POSITIVE REACTIONS ON CELLS P1 AND P2 OF THE FIRST FOLLOWING KNOWN NEGATIVE DONOR SAMPLE. THE ANTI-C TITRE WAS FOUND TO BE < 1:100. THE ANTI-D TITRE WAS FOUND TO BE > 1:3200. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352951 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG, LOT 8245170-05, EXP. 05/08/2014| BIOTESTCELL 3, LOT 8323031-00, EXP. 07/23/2013| AHG, LOT 8245170-05, EXP. 05/08/2014| BIOTESTCELL 3, LOT 8323031-00, EXP. 07/23/2013