BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO INFINITY

    MDR report key: 5636240 · Received May 6, 2016

    Report

    Report Number
    9610824-2016-00030
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 6, 2016
    Report Date
    July 27, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK150327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: IN OUR INITIAL REPORT, THE SUSPECT MEDICAL DEVICE NAME GIVEN WAS WRONG. IT SHOULD NOT HAVE STATED "TANGO OPTIMO" BUT "TANGO INFINITY". ALSO IN PMA#: THE PMA/510(K) WAS STATED AS "BK080013" WHERE IT SHOULD HAVE BEEN "BK150327". WE ARE MOST SORRY FOR THIS MISTAKE. THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A CUSTOMER TRAINING CONDUCTED BY AN BMD SPECIALIST, THE FOLLOWING INCIDENT OCCURED: A SAMPLE WAS PROCESSED ON TANGO INFINITY, AND THIS TESTING YIELDED UNUSUAL TEST RESULTS. NO FALSE POSITIVE OR FALSE NEGATIVE TEST RESULT WAS FILED BUT THE IMAGES LOOKED UNUSUAL AND QUALITY CONTROL FAILED. THE IMAGES DID NOT PASS VISUAL VALIDATION. INVESTIGATION OF THIS INCIDENT SHOWED THAT AN ERYTYPE RH + K PLATE WAS LOADED ON TANGO INFINITY. DURING THE STRIP BARCODE READING PROCESS A SECOND PLATE (SOLIDSCREEN II STRIP PLATE) WAS INSERTED INTO THE PLATE LOADING AREA, ALTHOUGH THE PLATE LOADING CARRIAGE WAS STILL IN TRANSPORT POSITION. THE BARCODE OF THIS SECOND PLATE WAS READ AND TRANSFERRED TO THE INVENTORY AS SOON AS IT WAS PLACED INTO THE PLATE LOADING STATION. THIS ACTION RESULTED IN OCCURRENCE OF A FATAL ERROR 45$01$51 (LOST STEPS PLATE MOVER), BECAUSE THE PLATE WAS BLOCKING THE PLATE LOADING CARRIAGE TO GO BACK TO THE INITIAL LOADING POSITION. THE SOLIDSCREEN II STRIP PLATE WAS REMOVED BUT THE INVENTORY STILL SHOWED THE SOLIDSCREEN II STRIP PLATE, WHILE THE ERYTYPE RH + K PLATE WAS LOADED ON THE SAME LEVEL POSITION, EVEN AFTER THE INITIALIZATION WAS FINISHED. THE TIME SLOT FOR THIS TO HAPPEN IS SO SMALL THAT OUR R&D COULD NOT REPRODUCE THIS ERROR. BECAUSE OF THIS ERROR, FOR THE ABI11 PANEL ASSAY THE ERYTYPE RH + K PLATE WAS USED INSTEAD OF A SOLDISCREEN II STRIP PLATE, WHICH LEADS POTENTIALLY TO A WRONG RESULT. THE CUSTOMER'S COMPLAINT COULD BE CONFIRMED AND FURTHER ACTIONS WERE INITIATED (INITIATION OF A CAPA AND FSCA). A SOFTWARE UPDATE WILL BE PROVIDED VERY SOON THAT PREVENTS INCORRECT ASSIGNMENT OF RESULTS DUE TO LOADING OF A SECOND PLATE WHILE THE PLATE LOADING CARRIAGE IS IN TRANSPORT POSITION. IN THE INTERIM, THE CUSTOMERS WERE ADVISED TO ENSURE THE PLATE LOADING CARRIAGE HAS COMPLETELY RETURNED TO THE LOADING POSITION BEFORE LOADING A NEW MICROPLATE.

    Description of Event or Problem · 1

    DURING A CUSTOMER TRAINING CONDUCTED BY AN BMD SPECIALIST, THE FOLLOWING INCIDENT OCCURED: A SAMPLE WAS PROCESSED ON TANGO INFINITY, USING AN ERYTYPE S RH+K TYPE PLATE INSTEAD OF A SOLID SCREEN STRIP PLATE. THIS TESTING YIELDED UNUSUAL TEST RESULTS NO FALSE POSITIVE OR FALSE NEGATIVE TEST RESULT WAS FILED BUT THE IMAGES LOOKED UNUSUAL AND QUALITY CONTROL FAILED. THE IMAGES DID NOT PASS VISUAL VALIDATION. INVESTIGATION OF THIS INCIDENT IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293175 TANGO INFINITY AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1