BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2223602 · Received August 25, 2011

    Report

    Report Number
    1034569-2011-00122
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 25, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES: (B)(4) 2011 AND 0126. THIS SAMPLE RESULTED AS INV/POS WITH THE ASSAY DUE TO THE B CELL HAD A NOT ENOUGH LIQUID FLAG. WELL A4- VISUALLY THIS WELL IS NEGATIVE. WELL B4- VISUALLY THIS WELL IS POSITIVE, CELL BUTTON HAS A LARGE LACEY EDGE- INDICATIVE OF THE PRESENCE OF FIBRIN. WELL C4- VISUALLY THIS WELL IS POSITIVE. CELL BUTTON HAS A LARGE LACEY EDGE- INDICATIVE OF THE PRESENCE OF FIBRIN. WELL D4- VISUALLY THIS WELL IS POSITIVE. WELL E4- VISUALLY THIS WELL IS NEGATIVE. WELL F4- VISUALLY THIS WELL IS POSITIVE. WELL G4- VISUALLY THIS WELL IS NEGATIVE. DUE TO THE NTD RESULT OF THE FIRST TESTING OF THIS SAMPLE, THE SAMPLE WAS PLACED ON THE INSTRUMENT THE NEXT NIGHT FOR THE REFLEX ABO ASSAY. THIS TIME THE SAMPLE RESULTED AS TYPE B. DUE TO THE FACT THE INSTRUMENT HAD SEEN THE SAMPLE PREVIOUSLY AND HAD RESULTED THE SAMPLE AS RH POS, THE REFLEX ABO DID NOT REFLEX TO A WEAK D AND THE SAMPLE RESULT WAS UPDATED TO REFLECT A B POS RESULT. WELL A2- NEG RESULT / 11 REACTION STRENGTH- VISUALLY NEG. WELL B2- 4+ RESULT / 91 REACTION STRENGTH- VISUALLY POS. WELL C2- NEG RESULT / 16 REACTION STRENGTH- VISUALLY NEG. WELL D2- NEG RESULT / 16 REACTION STRENGTH- VISUALLY NEG. WELL E2- NEG RESULT / 17 REACTION STRENGTH- VISUALLY NEG. WELL F2- 3+ RESULT / 74 REACTION STRENGTH- VISUALLY POS. WELL G2- NEG RESULT / 10 REACTION STRENGTH- VISUALLY NEG. THE NEXT DONATION FOR THIS DONOR WAS TESTED AND RESULTED AS B NEG. WELL A3- NEG RESULT / 12 REACTION STRENGTH- VISUALLY NEG. WELL B3- 4+ RESULT / 99 REACTION STRENGTH- VISUALLY POS. WELL C3- NEG RESULT / 15 REACTION STRENGTH- VISUALLY NEG. WELL D3- NEG RESULT / 12 REACTION STRENGTH- VISUALLY NEG. WELL E3- NEG RESULT / 14 REACTION STRENGTH- VISUALLY NEG. WELL F3- 4+ RESULT / 90 REACTION STRENGTH- VISUALLY POS. WELL G3- NEG RESULT / 17 REACTION STRENGTH- VISUALLY NEG. THIS SAMPLE REFLEXED TO THE WEAK D ASSAY. WELL C8- NEG RESULT / 16 REACTION STRENGTH- VISUALLY NEG. WELL D8- NEG RESULT / 14 REACTION STRENGTH- VISUALLY NEG. OBSERVATION OF INITIAL SAMPLE WELL IMAGES INDICATES THE PRESENCE OF FIBRIN. PER GALILEO OPERATOR MANUAL, CLOTTED SAMPLES SHOULD NOT BE TESTED ON THE GALILEO. UPON REVIEW OF SERVICE PERFORMED ON THE INSTRUMENT, UNEXPECTED RH POS RESULTS APPEAR TO BE DUE TO A FAILED RINSE PUMP CAUSING INADEQUATE WASHING OF SAMPLE PROBE. THE RINSE PUMP WAS REPLACED SHORTLY AFTER CUSTOMER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN RH MISTYPE WHEN TESTING A DONOR SAMPLE ON THE GALILEO. THE SAMPLE FROM THIS DONOR WAS INITIALLY TESTED AND RESULTED AS B POS. A NEW SAMPLE FROM THE SAME DONOR WAS TESTED ON RESULTED AS B NEG. THE CUSTOMER MANUALLY TESTED THE CURRENT SAMPLE BY TUBE METHOD AND RECEIVED A B NEG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1