BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 13657144 · Received March 2, 2022

    Report

    Report Number
    1034569-2022-00005
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    January 27, 2022
    Report Date
    June 27, 2022
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSF
    UDI-DI
    10888234000594
    PMA / PMN Number
    BK020053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATIONS WITH RETAINED PRODUCT, IMMUCOR DID NOT REPRODUCE THE CUSTOMER ISSUE WITH OUR IN-HOUSE SAMPLES. IT IS SUSPECTED THAT THE ANTI-S WAS INITIALLY IGM ONLY AND WAS ABLE TO BIND INDICATOR CELL LOT 221989 DIRECTLY BUT NOT LOT 221978. INDICATOR CELLS ARE MADE UP OF A POOL OF DONORS SO POSSIBLE THAT 221989 HAD MORE S+ CELLS THAN 221978. THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS (B)(4).

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATIONS WITH RETAINED PRODUCT, IMMUCOR DID NOT REPRODUCE THE CUSTOMER ISSUE WITH OUR IN-HOUSE SAMPLES. IT IS SUSPECTED THAT THE ANTI-S WAS INITIALLY IGM ONLY AND WAS ABLE TO BIND INDICATOR CELL LOT 221989 DIRECTLY BUT NOT LOT 221978. INDICATOR CELLS ARE MADE UP OF A POOL OF DONORS SO POSSIBLE THAT 221989 HAD MORE S+ CELLS THAN 221978. THE INTERNAL IMMUCOR REFERENCE FOR THIS EVENT IS (B)(4). THE MEDICAL DEVICE REPORT WAS REPORTED MARCH 2, 2022 IN ORDER TO BE SUBMITTED WITHIN THE REQUIRED 30-DAY TIMELINE. HOWEVER, THE INVESTIGATION OF THE EVENT WAS NOT COMPLETE AT THAT TIME, SO REPORT #1034569-2022-00005 WAS SUBMITTED BASED ON THE PARTIAL INFORMATION AVAILABLE AT THAT TIME. A SUPPLEMENT TO REPORT #1034569-2022-00005 HAS NOW BEEN SUBMITTED WHICH STATES THAT THE ISSUE WAS SAMPLE-RELATED AND IS A KNOWN LIMITATION OF THE CAPTURE TECHNOLOGY WHICH IS CLEARLY DESCRIBED IN THE INSTRUCTIONS FOR USE. ON (B)(6) 2022, THE AFFECTED PATIENT RECEIVED 3 UNITS OF BLOOD. ON (B)(6) 2022 THE PATIENT RECEIVED 1 UNIT OF BLOOD AND A FEBRILE TRANSFUSION REACTION WAS NOTED. ON (B)(6) 2022, THE PATIENT RECEIVED 1 UNIT OF BLOOD AND ANOTHER TRANSFUSION REACTION WAS OBSERVED; THE DOCTORS AT THE SITE ATTRIBUTED THIS REACTION DOWN TO TACO (TRANSFUSION ASSOCIATED CIRCULATORY OVERLOAD). TACO CANNOT BE PREVENTED BY IMMUNOLOGIC SCREENING. ON MARCH 17, 2022, THE CUSTOMER NOTIFIED IMMUCOR THAT THEY HAD RECEIVED RESULTS BACK FROM A REFERENCE LAB. THE SAMPLE WAS TESTED BY REFERENCE LAB WHO DETECTED ANTI-S. DTT TREATMENT OF THE PLASMA SHOWED A CLEAR REDUCTION IN ANTIBODY ACTIVITY BUT NOT COMPLETELY NEGATIVE. THIS SUGGESTS THE ANTIBODY IN THIS SAMPLE IS PRIMARILY IGM. THE SIGNIFICANT IGM COMPONENT OF THE ANTIBODY INDICATES THAT IT WAS NEWLY FORMED, AND THE IGG COMPONENT WAS BELOW THE LEVEL OF DETECTION OF THE ASSAY. PER THE CAPTURE-R READY-SCREEN (3) INSTRUCTIONS FOR USE: "CAPTURE-R READY-SCREEN (3) IS INTENDED FOR USE IN THE DETECTION OF UNEXPECTED IGG ANTIBODIES TO RED BLOOD CELLS BY MANUAL, SEMI-AUTOMATED OR AUTOMATED SOLID PHASE RED BLOOD CELL ADHERENCE METHODS."; "SPECIFICITIES OF PRESUMED SIGNIFICANCE, THAT ARE WHOLLY IGM IN NATURE (IE, IGM ANTI-K OR IGM ANTI-E) MAY FAIL TO REACT IN THIS ASSAY."; "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED." THE ADVERSE EVENT DESCRIBED IN REPORT #1034569-2022-00005 WAS DETERMINED TO BE ISOLATED AND CAUSED BY THE CONDITION OF THE AFFECTED PATIENT. THE IMMUCOR PRODUCT WAS DETERMINED TO BE OPERATING WITHIN ACCEPTABLE PERFORMANCE PARAMETERS (AND LIMITATIONS).

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED A SUSPECTED DELAYED TRANSFUSION REACTION WITH A PATIENT WHOSE SAMPLES WERE INITIALLY NEGATIVE BY SCREEN AND ID, BUT ANTI-S WAS IDENTIFIED WITH LATER SAMPLE.

    Description of Event or Problem · 0

    ON FEBRUARY 2, 2022, A CUSTOMER REPORTED A SUSPECTED DELAYED TRANSFUSION REACTION WITH A PATIENT WHOSE SAMPLES WERE INITIALLY NEGATIVE BY SCREEN AND ID, BUT ANTI-S WAS IDENTIFIED WITH LATER SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788417 CAPTURE-R READY INDICATOR RED CELLS KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS KSF IMMUCOR, INC. 0006427 221978 10888234000594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown