BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO LUMENA

    MDR report key: 18927577 · Received March 19, 2024

    Report

    Report Number
    1034569-2024-00005
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 19, 2024
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMMUCOR CONDUCTED A THOROUGH INVESTIGATION, AND THE FOLLOWING ARE THEIR FINDINGS. IMMUCOR RECEIVED 2 TUBES OF PLASMA - ONE WAS MARKED AS 'A PRE-TRANSFUSION' AND THE OTHER WAS MARKED AS 'B PRE-TRANSFUSION'. IMMUCOR ALSO RECEIVED 3 SETS OF POST-TRANSFUSION SAMPLES: ONE SET CONSISTED OF 1 TUBE OF SERUM AND 1 CORRESPONDING TUBE OF RED CELLS. BOTH WERE LABELED AS '1'; ONE SET CONSISTED OF 1 TUBE OF PLASMA AND 1 CORRESPONDING TUBE OF RED CELLS. BOTH WERE LABELED AS '2'; THE LAST SET CONSISTED OF 1 TUBE OF PLASMA AND 1 CORRESPONDING TUBE OF RED CELLS. BOTH WERE LABELED AS '3'. IMMUCOR ALSO RECEIVED 2 LAVENDER TOP TUBES CONTAINING RED BLOOD CELLS. 1 TUBE WAS LABELED AS 'A' WITH BARCODE 15-24-046-08366A, AND THE OTHER TUBE WAS LABELED AS 15-24-046-08902B. ALL SERUM AND PLASMA SAMPLES WERE YELLOW IN COLOR SHOWING NO SIGNS OF HEMOLYSIS. SAMPLES WERE ACCEPTABLE FOR TESTING. IMMUCOR RECEIVED 1 POUCH OF CRRS3 LOT R561. THE POUCH WAS SLIGHTLY OPENED, BUT THE HUMIDITY INDICATOR WAS BLUE. THERE WAS A DESICCANT, 11 STRIPS, AND 1 PLATE FRAME. THE STRIPS AND PLATE FRAME ALL READ AS R561. IMMUCOR RECEIVED 1 POUCH OF CRRID LOT ID463. THE POUCH WAS SLIGHTLY OPENED, BUT THE HUMIDITY INDICATOR WAS BLUE. THERE WAS A DESICCANT, 8 STRIPS, AND 1 PLATE FRAME. THE STRIPS AND PLATE FRAME ALL READ AS ID463. IMMUCOR PERFORMED A SCREEN ASSAY FOR QC ON THE ECHO LUMENA USING RETENTION WB CORQC LOT 236455, RETENTION CRRS3 LOT R561, AND RETENTION CRRIRC LOT 221517. THE CONTROLS PERFORMED AS EXPECTED. LEVEL 1 AND LEVEL 2 RESULTED POSITIVE AS EXPECTED. THERE WAS NO UNEXPECTED NEGATIVE REACTIVITY OBSERVED. RETENTION PRODUCT PERFORMED AS EXPECTED. IMMUCOR PERFORMED A SCREEN ASSAY ON THE ECHO LUMENA USING ALL RETURNED SAMPLES (2 PRE-TRANSFUSION AND 3 POST-TRANSFUSION) WITH RETENTION CRRS3 LOT R561 AND RETENTION CRRIRC LOT 221517. CONTROLS PERFORMED AS EXPECTED. ALL RETURNED SAMPLES RESULTED POSITIVE FOR CELL 1. STRENGTH OF REACTIVITY RANGED FROM 1+ TO 2+. IMMUCOR PERFORMED A SCREEN ASSAY ON THE ECHO LUMENA USING ALL RETURNED SAMPLES (2 PRE-TRANSFUSION AND 3 POST-TRANSFUSION) WITH RETURNED CRRS3 LOT R561 AND RETENTION CRRIRC LOT 221517. CONTROLS PERFORMED AS EXPECTED. ALL RETURNED SAMPLES RESULTED POSITIVE FOR CELL 1. STRENGTH OF REACTIVITY WAS 1+. IMMUCOR PERFORMED A SCREEN ASSAY ON THE ECHO LUMENA USING POST-TRANSFUSION SAMPLE #2, WHICH HAD THE MOST PLASMA LEFT AFTER PREVIOUS TESTING. THE SAMPLE WAS TESTED WITH RETENTION CRRS3 LOT R561 AND A DIFFERENT CRRIRC, RETENTION LOT 221524. CONTROLS PERFORMED AS EXPECTED. THE RETURNED POST-TRANSFUSION SAMPLE #2 RESULTED POSITIVE WITH CELL 1. STRENGTH OF REACTIVITY WAS 1+. IMMUCOR PERFORMED A SCREEN ASSAY ON THE ECHO LUMENA USING BOTH PRE-TRANSFUSION SAMPLES POOLED TOGETHER. WE WERE HOPING TO HAVE ENOUGH SAMPLE TO TEST WITH A DIFFERENT RETENTION PLATE, CRRS3 LOT R560. HOWEVER, THE SAMPLE VOLUME WAS TOO LOW, AND AN INVALID WAS GENERATED BY THE ECHO. IMMUCOR WAS UNABLE TO REPRODUCE THE CUSTOMER'S OBSERVATION OF NEGATIVE REACTIVITY WITH THE RETURNED SAMPLES. IMMUCOR PERFORMED A READY ID ASSAY ON THE ECHO LUMENA USING RETENTION CRRID LOT ID463 AND RETENTION CRRIRC LOT 221517. PLATE CONTROLS PERFORMED AS EXPECTED. THE POSITIVE CONTROL RESULTED POSITIVE SHOWING THAT ANTIBODY COULD BE DETECTED ON THE PLATE. IMMUCOR PERFORMED A READY ID ASSAY ON THE ECHO USING ALL RETURNED SAMPLES (2 PRE-TRANSFUSION AND 3 POST-TRANSFUSION) WITH RETENTION CRRID LOT ID463 AND RETENTION CRRIRC LOT 221517. PLATE CONTROLS PERFORMED AS EXPECTED. ALL RETURNED SAMPLES RESULTED NEGATIVE. IMMUCOR PERFORMED A READY ID ASSAY ON THE ECHO USING ALL RETURNED SAMPLES (2 PRE-TRANSFUSION AND 3 POST-TRANSFUSION) WITH RETURNED CRRID LOT ID463 AND RETENTION CRRIRC LOT 221517. PLATE CONTROLS PERFORMED AS EXPECTED. ALL RETURNED SAMPLES RESULTED NEGATIVE. IMMUCOR PERFORMED A READY ID ASSAY ON THE ECHO LUMENA USING POST-TRANSFUSION SAMPLE #2, WHICH HAD THE MOST PLASMA LEFT AFTER PREVIOUS TESTING. THE SAMPLE WAS TESTED WITH RETENTION CRRID LOT ID463 AND A DIFFERENT CRRIRC, RETENTION LOT 221524. PLATE CONTROLS PERFORMED AS EXPECTED. THE RETURNED SAMPLE #2 RESULTED NEGATIVE. IMMUCOR PERFORMED AN AB_ID ASSAY ON THE NEO IRIS USING BOTH RETURNED PRE-TRANSFUSION SAMPLES POOLED TOGETHER AND ALL THREE RETURNED POST-TRANSFUSION SAMPLES POOLED TOGETHER. BOTH PRE AND POST POOLED SAMPLES WERE TESTED WITH RETENTION CRRID LOT ID463 AND RETENTION CRRIRC LOT 221524. PLATE CONTROLS PERFORMED AS EXPECTED. BOTH PRE AND POST POOLED SAMPLES RESULTED NEGATIVE. WE WERE ABLE TO REPRODUCE YOUR NEGATIVE REACTIVITY WITH THE RETURNED SAMPLES. IMMUCOR PERFORMED A DAT AND COOMBS BATTERY ON THE RED BLOOD CELLS FROM RETURNED PRE-TRANSFUSION SAMPLE A AND POST-TRANSFUSION SAMPLE #1. CONTROLS PERFORMED AS EXPECTED. THE PRE-TRANSFUSION SAMPLE A RESULTED: 1+ WITH ANTI-IGG,-C3D AND NEGATIVE WITH ANTI-IGG AT IMMEDIATE SPIN; W+ WITH ANTI-C3B,-C3D AFTER A 5 MINUTE ROOM TEMPERATURE INCUBATION. THE POST-TRANSFUSION SAMPLE #1 RESULTED: 1+ WITH ANTI-IGG,-C3D AND NEGATIVE WITH ANTI-IGG AT IMMEDIATE SPIN; W+ WITH ANTI-C3B,-C3D AFTER A 5 MINUTE ROOM TEMPERATURE INCUBATION. THE RED BLOOD CELLS FROM RETURNED PRE-TRANSFUSION SAMPLE A RESULTED ANTIGEN NEGATIVE FOR LEA AND LEB. THE PATIENT'S LEWIS PHENOTYPE IS LE(A-B-). FROM OUR TESTING, ONLY 1 LE(A+) RED CELL RESULTED POSITIVE OUT OF 5 THAT WERE TESTED. MOST LEWIS ANTIBODIES DO NOT SHOW UP IN CAPTURE METHODOLOGY BECAUSE THEY ARE NOT IGG ANTIBODIES AND ARE CONSIDERED CLINICALLY INSIGNIFICANT. IN OUR TESTING, WE DID RECEIVE REACTIVITY SHOWING THAT THERE IS AN ANTIBODY WITH IGG CHARACTERISTICS, SPECIFICITY UNKNOWN. OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. ALL RETENTION TESTING RESULTED AS EXPECTED. ON FEBRUARY 21, 2024 IMMUCOR USED REMOTE ACCESS TO REVIEW THE INSTRUMENT RESULTS FROM FEBRUARY 8, 2024; CAMERA REPORT WAS ACCEPTABLE AND NO INSTRUMENT ERRORS WERE FOUND. ON FEBRUARY 29, 2024 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) INSPECTED ECHO LUMENA INSTRUMENT SERIAL NUMBER M20978 AT THE CUSTOMER SITE. THE FSE COMPLETED THE UNEXPECTED REACTION CHECKLIST SUCCESSFULLY. THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULTS ON THE ECHO LUMENA INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559374 ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female