BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    MDR report key: 4130138 · Received September 30, 2014

    Report

    Report Number
    2250051-2014-00101
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: UNABLE TO PERFORM RETAIN TESTING SINCE COMPLAINT WAS REPORTED AFTER THE PRODUCT EXPIRED. CUSTOMER REPORTED INCIDENT ON (B)(6) 2014, PRODUCT EXPIRED 19AUG2014. OCD PERFORMED BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY AND DONOR COMPLAINT REVIEW. SAMPLE WAS NOT RETURNED TO OCD FOR FURTHER INVESTIGATION. DONOR WAS DEFERRED FROM FUTURE USE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER (BB SUPERVISOR) REPORTING A (B)(6) REACTION TO CELL# 5 (FYA NEG, FYB POS) TO THE 0.8% RESOLVE PANEL A LOT# VRA202 TO A PATIENT THAT WAS LATER CONFIRMED TO HAVE AN ANTI-FYB. THE PATIENT WAS INITIALLY TESTED ON (B)(6) 2014 AND A POSITIVE ANTIBODY SCREEN WAS OBSERVED. NO DETAILS PROVIDED REGARDING THE ANTIBODY SCREEN OTHER THEN IT BEING (B)(6). THE CUSTOMER WENT ON AND TESTED THE PATIENT SAMPLE AGAINST THE 0.8% RESOLVE PANEL A LOT# VRA202 . CUSTOMER REPORTS THAT THEY WERE UNABLE TO IDENTIFY ANY ANTIBODY AND WAS ABLE TO RULE OUT ANTI-FYB BASED ON THE NEGATIVE REACTION AGAINST THE HOMOZYGOUS CELL#5. REACTIVITY ON THE PANEL WERE VERY WEAK FOR THOSE DONORS THAT REACTED. THE PATIENT IN QUESTION WAS TRANSFUSED 1 UNIT OF ABO COMPATIBLE BLOOD WITH NOT REPORTED IMMEDIATE TRANSFUSION REACTION. CROSSMATCH CONFIRMED TO BE PERFORMED BY THE AHG CROSSMATCH PERFORMED IN THE MTS ANTI-IGG GEL CARD AND CONFIRMED COMPATIBLE. PATIENT CONFIRMED TO BE DAT NEGATIVE. NO PREVIOUS HISTORY ON THE PATIENT PRIOR TO (B)(6) 2014 TESTING. ISSUE STARTED ON: (B)(6) 2014. FREQUENCY: X2 SAMPLES SAME PATIENT; CELL AFFECTED: CELL#5; METHODOLOGY USED: MANUAL GEL; INCUBATION TIME (FOR MANUAL TEST ONLY): 15MIN; PATTERN OBSERVED: CELL#5 NEGATIVE; REACTION GRADE OBTAINED: NEGATIVE; CUSTOMER WAS EXPECTING: POSITIVE; TEST REPEATED: YES. RESULT OBTAINED BY REPEATING: NEGATIVE. METHOD USED TO REPEAT: SAME. OTHER RELEVANT DETAILS: ANOTHER SAMPLE WAS RECEIVED ON (B)(4)14 AND ONCE AGAIN THE PATIENT'S ANTIBODY SCREEN WAS POSITIVE AND THE PATIENT AGAIN WAS TESTED WITH 0.8% RESOLVE PANEL A LOT# VRA202 AND RESULTS WERE CONSISTENT WITH THE ORIGINAL PANEL, ONLY STRONGER 2+ REACTIONS AS DESCRIBED BY THE CUSTOMER BUT CELL#5 AGAIN CONFIRMED TO BE NEGATIVE. CUSTOMER REPORTS SENDING THE SAMPLE OUT THAT WAS COLLECTED ON (B)(6) 2014 BASED ON THE 3+ DIRECT COOMBS THAT WAS NOW OBSERVED. CUSTOMER INDICATES THAT THEIR REFERENCE LABORATORY HAD IDENTIFIED AN ANTI-FYB AND WAS ABLE TO ELUTE THE ANTI-FYB FROM THE PATIENT'S RED CELLS. ANTIBODY IDENTIFIED USING TRADITIONAL TUBE BY LISS AND PEG. CUSTOMER SUSPECTS A DELAYED TRANSFUSION REACTION. THE PACKED CELL UNIT TRANSFUSED ON THE PATIENT BACK ON (B)(6) 2014 HAS NOT AND WILL NOT BE TESTED FOR THE FYB ANTIGEN. CUSTOMER DOES NOT HAVE THE UNIT OR SEGMENT ON HAND ANYMORE. CUSTOMER INDICATES THEIR CONCERN WITH THE CELL#5 TO THE 0.8% RESOLVE PANEL A LOT # VRA202 THAT CONSISTENTLY DID NOT REACT WITH THE PATIENT AND WAS USED TO RULE ANTI-FYB. CUSTOMER REPORTS TESTING THE CELL#5 FOR THE FYB ANTIGEN USING THE ORTHO ANTI-FYB AND NOTED NO REACTIVITY. CELL#5 WAS INCREASED TO A 3% CELL CONCENTRATION AND TESTED AS PER FYB IFU PROTOCOL. ALL LISTED OCD PRODUCTS HAVE BEEN CONFIRMED TO HAVE NORMAL APPEARANCE AND HAS BEEN STORED ACCORDING TO THE PACKAGE INSERT INDICATIONS. CUSTOMER REQUESTING OCD TO FURTHER INVESTIGATE THE CELL#5 CONCERN. CUSTOMER REQUESTING A FOLLOW UP INTO THE REPORTED CONCERN AND RESULTS OF THE INVESTIGATION TO THE CELL#5 CONCERN. OCD HAS AGREED TO FOLLOW UP WITH THE CUSTOMER AS REQUESTED. ONCE RESULTS OF THE INVESTIGATION ARE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607916 ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other