BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEIX ULTRIO ELITE ASSAY

    MDR report key: 7298169 · Received February 26, 2018

    Report

    Report Number
    2032600-2018-00001
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    November 26, 2017
    Report Date
    August 3, 2018
    Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Product Code
    MZF
    PMA / PMN Number
    BL125652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP INFORMATION (FINAL): GDS SAN DIEGO TESTED THE FIRST AND THIRD SAMPLES IN THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 ASSAY. NEITHER SAMPLE WAS DETECTED INDICATING THAT THE SAMPLES WERE LESS THAN 20 IU/ML AND WERE BELOW THE LEVEL OF QUANTITATION OF THE ASSAY. THE THIRD SAMPLE WAS ALSO SENT FOR SEROLOGY TESTING. THE RESULTS WERE NEGATIVE. THIS ADDITIONAL DATA IS SHOWN BELOW. THE RETURNED SAMPLES COULD NOT BE SEQUENCED DUE TO THE LOW TITER OF THE VIRUS. TESTING OF RETURNED SAMPLES: SAMPLE ID: 1ST DONATION SAMPLE #(B)(6). TEST: COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0. RESULT: <20 IU/ML. INTERPRETATION: NOT DETECTED. SAMPLE ID: 3RD SAMPLE #(B)(6). TEST: COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0. RESULT: <20 IU/ML. INTERPRETATION: NOT DETECTED. SAMPLE ID: 3RD SAMPLE #(B)(6). TEST: ARUP TEST CODE 0020454: HEPATITIS B VIRUS PANEL, CHRONIC WITH REFLEX TO HBSAG CONFIRMATION. RESULTS: HBSAG - NEGATIVE, ANTI-HBS - NEGATIVE, HBEAG - NEGATIVE, ANTI-HBE - NEGATIVE INTERPRETATION: THE RESULT PATTERN OF THE HBSAG, ANTI-HBS, HBEAG, AND ANTI-HBE INDICATES NO SEROLOGICAL EVIDENCE OF PAST OR CHRONIC HBV INFECTION. IN ADDITION, THERE IS NO EVIDENCE THIS PATIENT HAS DEVELOPED IMMUNITY FOLLOWING HBV VACCINATION. BASED ON THE DEVICE HISTORY RECORD (DHR), ULTRIO ELITE ML 180939 WAS RELEASED MEETING QC SPECIFICATIONS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING OF THIS LOT THAT WOULD IMPACT ASSAY PERFORMANCE. A SEARCH OF COMPLAINTS RELATED TO THIS ISSUE WAS PERFORMED. NO RELATED QUALITY EVENTS WERE FOUND FOR THIS LOT/BATCH OF PRODUCT. REVIEW OF THE RUN REPORTS PROVIDED FOR THIS ISSUE SHOWED THAT THE ASSAY AND INSTRUMENT PERFORMED AS EXPECTED. BASED ON THE CALIBRATORS, THE RESULTS WERE VALID AND WERE WITHIN SPECIFICATION. THE INITIAL DONATION WAS REACTIVE IN 1/3 REPLICATES IN THE ULTRIO ELITE ASSAY. IT WAS NONREACTIVE IN THE DISCRIMINATORY ASSAYS. AN ADDITIONAL 10 REPLICATES WERE ALSO NONREACTIVE IN ULTRIO ELITE. THE DONOR RETURNED AND GAVE A SECOND SAMPLE, WHICH WAS REACTIVE IN 6/10 REPLICATES IN THE ULTRIO ELITE (UE) DHBV ASSAY, AND NONREACTIVE IN THE UE DHCV AND UE DHIV ASSAYS. THIS INDICATED PRESENCE OF HBV. TO CONFIRM, THE SECOND DONATION WAS ALSO TESTED FOR HBV SEROLOGY, BUT ALL RESULTS WERE NEGATIVE. GDS SAN DIEGO TESTED THE FIRST AND THIRD SAMPLES IN THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 ASSAY. NEITHER SAMPLE WAS DETECTED INDICATING THAT THE SAMPLES WERE LESS THAN 20 IU/ML AND WERE BELOW THE LEVEL OF QUANTITATION OF THE ASSAY. THE THIRD SAMPLE WAS ALSO SENT FOR SEROLOGY TESTING. THE RESULTS WERE NEGATIVE. THE RETURNED SAMPLES COULD NOT BE SEQUENCED DUE TO THE LOW TITER OF THE VIRUS. CONCLUSION: THE ULTRIO ELITE ASSAY AND PANTHER INSTRUMENT PERFORMED AS EXPECTED.

    Description of Event or Problem · 0

    ON 08JAN2018, GRIFOLS CUSTOMER, (B)(6) IN ITALY, REPORTED A DISCREPANT HBV RESULT FOR A DONOR SAMPLE (COLLECTION DATE: 26NOV2017) TESTED WITH PROCLEIX ULTRIO ELITE ASSAY MASTER LOT (ML) 180939.THE INITIAL DONOR SAMPLE TESTED ON 2032600-2018-00001 2017 YIELDED A NONREACTIVE RESULT WITH AN S/CO OF 0.93. AS THE INITIAL RESULT WAS NEAR THE S/CO CUTOFF OF 1.0, THE LABORATORY PROFESSIONAL OPTED TO RETEST TWO MORE REPLICATES OF THE SAMPLE ON THE SAME DAY YIELDING S/CO VALUES OF 1.04 (REACTIVE) AND 0.82 (NON-REACTIVE). THE SAMPLE WAS THEN TESTED AGAIN ON THE SAME DAY IN EACH DISCRIMINATORY ASSAY FOR HBV, HCV AND HIV. THE RESULTS IN THE THREE ASSAYS WERE NONREACTIVE, S/CO VALUES: DHBV 0.00, DHCV 0.00, DHIV 0.11. ON (B)(6) 2017, TEN REPLICATES OF THE DONOR SAMPLE WAS TESTED IN THE PROCLEIX ULTRIO ELITE ASSAY YIELDING ALL NONREACTIVE RESULTS WITH S/CO VALUES OF 0.09, 0.05, 0.08, 0.07, 0.07, 0.10, 0.07, 0.07, 0.06 AND 0.05. SEROLOGY RESULTS FOR THIS DONOR SAMPLE WERE NONREACTIVE FOR HBSAG, AG P24/AB ANTI-HIV1/2, ANTI CORE AND ANTI HCV. DUE TO THE REACTIVE RESULT FROM THE REPEAT TESTING, THE DONATION WAS DISCARDED. A SECOND SAMPLE WAS COLLECTED FROM THE DONOR ON (B)(6) 2017 FOR ADDITIONAL TESTING. NINE REPLICATES OF THE 2ND DONATION WERE TESTED IN THE DISCRIMINATORY HBV (DHBV) ASSAY AND YIELDED A REACTIVE RESULT FOR 6 OUT OF THE 9 REPLICATES WITH S/CO VALUES OF 1.39, 1.26, 0.38, 0.82, 0.83, 1.19, 2.67, 1.18 AND 1.62. THE SAMPLE WAS ALSO TESTED IN TRIPLICATE WITH THE DISCRIMINATORY ASSAYS FOR HCV AND HIV AND ALL RESULTS WERE NONREACTIVE (S/CO VALUE: DHCV 0.00, 0.00, 0.00; DHIV 0.13, 0.09, 0.10).SEROLOGY TEST RESULTS COMPLETED ON 06DEC2017 WERE REPORTED TO BE NON-REACTIVE FOR HBSAG, AG P24/AB ANTI-HIV1/2, ANTI CORE AND ANTI HCV. A THIRD SAMPLE WAS COLLECTED FROM THE DONOR ON 14FEB2018 FOR ADDITIONAL TESTING. ONE REPLICATE WAS TESTED ON 20FEB2018 IN THE PROCLEIX ULTRIO ELITE ASSAY AND THE DISCRIMINATORY HBV ASSAY. THE ULTRIO ELITE RESULT WAS NONREACTIVE WITH A S/CO OF 0.31 AND THE DHBV ASSAY RESULT WAS NONREACTIVE WITH A S/CO OF 0.54. AT THIS TIME, THE DONOR HAS BEEN DEFERRED FROM DONATING BLOOD UNTIL FURTHER NOTICE. AN INVESTIGATION IS ONGOING FOR THE DISCREPANT HBV RESULT. REMAINING SAMPLE FROM THE FIRST AND THIRD COLLECTIONS ARE BEING SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 180939 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 1

    ON (B)(6) 2018, GRIFOLS CUSTOMER, (B)(6) IN (B)(6), REPORTED A DISCREPANT (B)(6) RESULT FOR A DONOR SAMPLE (COLLECTION DATE: (B)(6) 2017) TESTED WITH PROCLEIX ULTRIO ELITE ASSAY MASTER LOT (ML) 180939. THE INITIAL DONOR SAMPLE TESTED ON (B)(6) 2017 YIELDED A (B)(6) RESULT WITH AN S/CO OF 0.93. AS THE INITIAL RESULT WAS NEAR THE S/CO CUTOFF OF 1.0, THE LABORATORY PROFESSIONAL OPTED TO RETEST TWO MORE REPLICATES OF THE SAMPLE ON THE SAME DAY YIELDING S/CO VALUES OF 1.04 ((B)(6)) AND 0.82 ((B)(6)). THE SAMPLE WAS THEN TESTED AGAIN ON THE SAME DAY IN EACH DISCRIMINATORY ASSAY FOR (B)(6). THE RESULTS IN THE THREE ASSAYS WERE (B)(6), S/CO VALUES: (B)(6) 0.00, (B)(6) 0.00, (B)(6) 0.11. ON (B)(6) 2017, TEN REPLICATES OF THE DONOR SAMPLE WAS TESTED IN THE PROCLEIX ULTRIO ELITE ASSAY YIELDING ALL NONREACTIVE RESULTS WITH S/CO VALUES OF 0.09, 0.05, 0.08, 0.07, 0.07, 0.10, 0.07, 0.07, 0.06 AND 0.05. SEROLOGY RESULTS FOR THIS DONOR SAMPLE WERE (B)(6) FOR (B)(6). DUE TO THE (B)(6) RESULT FROM THE REPEAT TESTING, THE DONATION WAS DISCARDED. A SECOND SAMPLE WAS COLLECTED FROM THE DONOR ON (B)(6) 2017 FOR ADDITIONAL TESTING. NINE REPLICATES OF THE 2ND DONATION WERE TESTED IN THE DISCRIMINATORY (B)(6) ASSAY AND YIELDED A (B)(6) RESULT FOR 6 OUT OF THE 9 REPLICATES WITH S/CO VALUES OF 1.39, 1.26, 0.38, 0.82, 0.83, 1.19, 2.67, 1.18 AND 1.62. THE SAMPLE WAS ALSO TESTED IN TRIPLICATE WITH THE DISCRIMINATORY ASSAYS FOR (B)(6) AND ALL RESULTS WERE (B)(6) (S/CO VALUE: (B)(6) 0.00, 0.00, 0.00; (B)(6) 0.13, 0.09, 0.10).SEROLOGY TEST RESULTS COMPLETED ON (B)(6) 2017 WERE REPORTED TO BE (B)(6) FOR (B)(6). A THIRD SAMPLE WAS COLLECTED FROM THE DONOR ON (B)(6) 2018 FOR ADDITIONAL TESTING. ONE REPLICATE WAS TESTED ON (B)(6) 2018 IN THE PROCLEIX ULTRIO ELITE ASSAY AND THE DISCRIMINATORY (B)(6) ASSAY. THE ULTRIO ELITE RESULT WAS (B)(6) WITH A S/CO OF 0.31 AND THE (B)(6) ASSAY RESULT WAS (B)(6) WITH A S/CO OF 0.54. AT THIS TIME, THE DONOR HAS BEEN DEFERRED FROM DONATING BLOOD UNTIL FURTHER NOTICE. AN INVESTIGATION IS ONGOING FOR THE DISCREPANT (B)(6) RESULT. REMAINING SAMPLE FROM THE FIRST AND THIRD COLLECTIONS ARE BEING SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML (B)(4) WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141429 PROCLEIX ULTRIO ELITE ASSAY HIV-1/2, HCV AND/OR HBV DEVICE MZF GRIFOLS DIAGNOSTIC SOLUTIONS INC. 180939

    Patients

    Seq Age Sex Outcome Treatment
    1 Other