BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECHO LUMENA

    MDR report key: 15705129 · Received October 31, 2022

    Report

    Report Number
    1034569-2022-00018
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Report Date
    October 31, 2022
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234002338
    PMA / PMN Number
    BK170135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SERIAL NUMBERS CONTINUED FROM: (B)(4). ADDITIONAL LOT NUMBERS CONTINUED FROM: R390, NU804, 504037E, E491 , 203901, 221098, DN138.

    Description of Event or Problem · 0

    A REVIEW OF EVENTS INDICATED THAT PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS FOR ANTIBODIES. A REVIEW INDICATED THAT SIXTEEN (16) PATIENT SAMPLE TESTS (OVER THIRTEEN EVENTS) USING THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED NINE (9) INACCURATE RESULTS FOR ABO AND RH TESTING. OF THE NINE (9) INACCURATE RESULTS; SEVEN (7) WERE RELATED TO ANTI-D AND TWO (2) WERE RELATED TO ANTI-B IN ADDITION, THE INSTRUMENT HAD UNEXPECTED FALSE NEGATIVE RESULTS FOR ANTIBODIES; INCLUDING: FOUR (4) FOR THE ANTI-E ANTIBODY; TWO (2) FOR THE ANTI-FYA ANTIBODY AND ONE (1) FOR THE ANTI-K ANTIBODY. IN EACH CIRCUMSTANCE, SUBSEQUENT TESTING OF RELEVANT REAGENT RETENTION LOTS PRODUCED ACCURATE RESULTS. ADDITIONAL INVESTIGATIONS RELATED TO QUALITY CONTROL PROCESSES; TEST PROCEDURES AND OTHER FACTS COULD NOT DETERMINE ANY DIRECT CAUSE OF THE MISSED ANTIBODY SCREENING AND THE MALFUNCTIONS ARE ALLOCATED AGAINST THE ANALYTICAL INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462470 ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM, PRODUCT CODE:KSZ KSZ IMMUCOR, INC. 0086998 504033E,221080,504035E,505896 10888234002338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown