BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO INFINITY

    MDR report key: 7376759 · Received March 28, 2018

    Report

    Report Number
    9610824-2018-00016
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969961719
    PMA / PMN Number
    BK150327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY MISSED AN ANTI-D WHEN TESTING WITH BIOTESTCELL I11 PLUS ON TANGO INFINITY. THE CUSTOMER RAN A TYPE AND SCREEN SAMPLE ON THE TANGO INFINITY WITH BIOTESTCELL-3, #8803021-00 AND THE ANTIBODY SCREEN WAS POSITIVE. WHEN PERFORMING AN ANTIBODY IDENTIFICATION WITH BIOTESTCELL-I 11 PLUS, # 8803011-00, ALL PANEL CELLS REACTED NEGATIVE. THE CUSTOMER REPEATED THE ANTIBODY SCREEN AND ANTIBODY PANEL WITH THE TUBE METHOD AND USING ORTHO REAGENTS AND IN THIS TEST THE SCREEN CELLS AND THE IDENTIFICATION PANEL SHOWED AN ANTI-D.THE CUSTOMER FILED HIS COMPLAINT SHORTLY BEFORE THE ALLEGEDLY DEFECTIVE PRODUCT WAS TO EXPIRE. THEREFORE OUR QUALITY CONTROL LABORATORY ALREADY STARTED WITH TESTING THEIR RETENTION SAMPLES. POSITIVE AND NEGATIVE CONTROLS (E.G. ANTI-D) AND DONOR SAMPLES WERE TESTED ON TANGO INFINITY. ALL REACTIONS WERE CORRECT. THEN THE ANTIGENICITY OF THE REAGENT RED BLOOD CELLS WAS DETERMINED IN PARALLEL. NO DISTINCT DIFFERENCES WERE FOUND.ONCE THIS TESTING WAS COMPLETED, THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. BUT AT THE TIME THE PATIENT SAMPLE ARRIVED ON OUR PREMISES, THE ALLEGEDLY DEFECTIVE PRODUCT BIOTESTCELL I11 PLUS HAD ALREADY EXPIRED. THEREFORE THE PATIENT SAMPLE WAS TESTED WITH THE CURRENT LOTS OF BIOTESTCELL-3, #8807011-00 AND BIOTESTCELL-I 11 PLUS, # 8807011-00 AND FOUND TO BE POSITIVE FOR ANTI-D. ALL SCREEN AND IDENTIFICATION RRBCS WITH AN ANTIGEN D REACTED STRONGLY POSITIVE (3-4). THERE WEREN`T ANY DIFFERENCES BETWEEN THE SCREEN AND IDENTIFICATION RRBCS PARTICULARLY WITH REGARD TO THE ANTIGENICITY.TESTING IN OUR QUALITY CONTROL LABORATORY SHOWED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO INFINITY.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY MISSED AN ANTI-D WHEN TESTING WITH BIOTESTCELL I11 PLUS ON TANGO INFINITY. THE CUSTOMER RAN A TYPE AND SCREEN SAMPLE ON THE TANGO INFINITY WITH BIOTESTCELL-3, # (B)(4) AND THE ANTIBODY SCREEN WAS POSITIVE. WHEN PERFORMING AN ANTIBODY IDENTIFICATION WITH BIOTESTCELL-I 11 PLUS, # (B)(4), ALL PANEL CELLS REACTED NEGATIVE. THE CUSTOMER REPEATED THE ANTIBODY SCREEN AND ANTIBODY PANEL WITH THE TUBE METHOD AND USING ORTHO REAGENTS AND IN THIS TEST THE SCREEN CELLS AND THE IDENTIFICATION PANEL SHOWED AN ANTI-D. THE CUSTOMER FILED HIS COMPLAINT SHORTLY BEFORE THE ALLEGEDLY DEFECTIVE PRODUCT WAS TO EXPIRE. THEREFOR OUR QUALITY CONTROL LABORATORY ALREADY STARTED WITH TESTING THEIR THE RETENTION SAMPLES. POSITIVE AND NEGATIVE CONTROLS (E.G. ANTI-D) AND DONOR SAMPLES WERE TESTED ON TANGO INFINITY. ALL REACTIONS WERE CORRECT. THEN THE ANTIGENICITY OF THE REAGENT RED BLOOD CELLS WAS DETERMINED IN PARALLEL. NO DISTINCT DIFFERENCES WERE FOUND. WHEN THIS TESTING WAS COMPLETED, THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. BUT AT THE TIME THE PATIENT SAMPLE ARRIVED ON OUR PREMISES, THE ALLEGEDLY DEFECTIVE PRODUCT BIOTESTCELL I11 PLUS HAD ALREADY EXPIRED. THEREFORE THE PATIENT SAMPLE WAS TESTED WITH THE CURRENT LOTS OF BIOTESTCELL-3, # (B)(4) AND BIOTESTCELL-I 11 PLUS, # (B)(4) AND FOUND TO BE POSITIVE FOR ANTI-D. ALL SCREEN AND IDENTIFICATION RRBCS WITH AN ANTIGEN D REACTED STRONGLY POSITIVE (3-4). THERE WEREN`T ANY DIFFERENCES BETWEEN THE SCREEN AND IDENTIFICATION RRBCS PARTICULARLY WITH REGARD TO THE ANTIGENICITY. TESTING IN OUR QUALITY CONTROL LABORATORY SHOWED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I11 PLUS 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 INFINITY WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. EVALUATION OF THE DATA IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220320 TANGO INFINITY AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 850000010 07611969961719

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3, LOT 8803021-00, EXP. 03/12/18| BIOTESTCELL 3, LOT 8803021-00, EXP. 03/12/18| BIOTESTCELL I11 PLUS,LOT 8803011-00,EXP. 03/12/18| BIOTESTCELL I11 PLUS,LOT 8803011-00,EXP. 03/12/18