BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEIX ULTRIO ELITE ASSAY

    MDR report key: 14163619 · Received April 20, 2022

    Report

    Report Number
    2032600-2022-00003
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    February 12, 2022
    Report Date
    September 12, 2022
    Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Product Code
    QHO
    UDI-DI
    00859882007603
    PMA / PMN Number
    BL125652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 12FEB2022, (B)(4) DISTRIBUTOR (B)(6) REPORTED FOUR HCV SEROLOGY POSITIVE SAMPLES THAT WERE NONREACTIVE IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY HCV ASSAY (UE DHCV) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN HCV QUANT, AND EACH HAD HCV TITER GREATER THAN EQUAL TO 35 IU/ML (ABOVE THE 2.4 IU/ML LOD OF THE UE DHCV ASSAY). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON 12FEB2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL 05APR2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS [?]POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE NONREACTIVE RESULTS IN THE ULTRIO ELITE DHCV ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM POSITIVE SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE DISCRIMINATORY ASSAYS PER THE PACKAGE INSERT. A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 703890 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA, AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS TYPE OF ERROR IN THE DHCV ASSAY FOR ML 703890 OR ANY OTHER MASTER LOT OVER THE LAST YEAR. DETAILS FOR SAMPLE HANDLING/ STORAGE AND OTHER TESTING PERFORMED HAVE BEEN REQUESTED. PRELIMINARY CONCLUSION: SPECIMEN HANDLING AND STORAGE HAS NOT BEEN RULED OUT AS THE ROOT CAUSE FOR THE NONREACTIVE DHCV RESULTS. THE PREVIOUS EVENTS SEARCH, AND QC RELEASE DATA DO NOT INDICATE AN HCV SENSITIVITY ISSUE WITH THE UE DHCV ASSAY. INSTRUCTIONS IN THE PACKAGE INSERT REGARDING DISCRIMINATORY TESTING (INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE DISCRIMINATORY ASSAYS) WERE NOT FOLLOWED BY THE CUSTOMER. SINCE THERE ARE 4 DIFFERENT DONORS, EACH DONOR HAS ITS OWN MDR. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE.

    Description of Event or Problem · 0

    ON 12FEB2022, (B)(6) HOSPITAL (KARACHI, PAKISTAN) REPORTED FOUR HCV SEROLOGY POSITIVE SAMPLES THAT WERE NONREACTIVE IN THE PROCLEIX ULTRIO ELITE DISCRIMINATORY HCV ASSAY (UE DHCV) MASTER LOT (ML) 703890. THE FOUR SAMPLES WERE ALSO TESTED IN HCV QUANT, AND EACH HAD HCV TITER GREATER THAN EQUAL TO 35 IU/ML (ABOVE THE 2.4 IU/ML LOD OF THE UE DHCV ASSAY). NO REMAINING SAMPLE VOLUME IS AVAILABLE FOR INVESTIGATION AND THERE IS NO OPTION FOR A NEW BLOOD DRAW. NO CUSTOMER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLES AND DONORS WERE BLOCKED FROM USE. THOUGH REPORTED TO GRIFOLS ON 12FEB2022, THE COMPLAINT WORK ORDER WAS NOT CREATED UNTIL 05APR2022. DURING QA REVIEW OF THE WORK ORDER, THE COMPLAINT WAS RECLASSIFIED AS [?]POTENTIAL HEALTH AND SAFETY COMPLAINTS" AND LATER THE PRODUCT QUALITY COMMITTEE DETERMINED THIS EVENT WAS MDR REPORTABLE. INVESTIGATION INTO THIS DELAY IS ONGOING. AN INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE FOR THESE NONREACTIVE RESULTS IN THE ULTRIO ELITE DHCV ASSAY. THE CUSTOMER IS USING THE DISCRIMINATORY ASSAYS TO CONFIRM POSITIVE SEROLOGY RESULTS, RATHER THAN INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE DISCRIMINATORY ASSAYS PER THE PACKAGE INSERT. A REVIEW OF THE QUALITY CONTROL DATA FOR ULTRIO ELITE ML 703890 WAS PERFORMED. THERE WERE NO RELATED QUALITY EVENTS FOUND FOR THIS LOT/BATCH OF PRODUCT AND THE PRODUCT MET ALL RELEASE CRITERIA, AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS TYPE OF ERROR IN THE DHCV ASSAY FOR ML 703890 OR ANY OTHER MASTER LOT OVER THE LAST YEAR. DETAILS FOR SAMPLE HANDLING/ STORAGE AND OTHER TESTING PERFORMED HAVE BEEN REQUESTED. PRELIMINARY CONCLUSION: SPECIMEN HANDLING AND STORAGE HAS NOT BEEN RULED OUT AS THE ROOT CAUSE FOR THE NONREACTIVE DHCV RESULTS. THE PREVIOUS EVENTS SEARCH, AND QC RELEASE DATA DO NOT INDICATE AN HCV SENSITIVITY ISSUE WITH THE UE DHCV ASSAY. INSTRUCTIONS IN THE PACKAGE INSERT REGARDING DISCRIMINATORY TESTING (INITIALLY SCREENING WITH THE ULTRIO ELITE MULTIPLEX ASSAY AND TESTING SAMPLES WITH REACTIVE RESULTS IN THE DISCRIMINATORY ASSAYS) WERE NOT FOLLOWED BY THE CUSTOMER. SINCE THERE ARE 4 DIFFERENT DONORS, EACH DONOR HAS ITS OWN MDR. SEE SECTION B6 FOR FURTHER INFORMATION. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE. FOLLOW-UP INFORMATION: UPDATED INFORMATION WAS RECEIVED FOLLOWING THE INITIAL REPORT INDICATING THE ACTUAL AWARENESS DATE FOR THIS EVENT WAS 31MAR2022. GRIFOLS REQUESTED ADDITIONAL INFORMATION REGARDING SAMPLE HANDLING. THE CUSTOMER INDICATED THE SEPARATE TUBES WERE USED FOR THE SEROLOGY TEST AND THE DHCV TEST AND THAT SAMPLES WERE STORED AT MINUS 40°C PRIOR TO DHCV TESTING. THE TESTING ALGORITHM USED BY THE CUSTOMER IS TO TEST SEROLOGY POSITIVE SAMPLES IN THE APPROPRIATE UE DISCRIMINATORY ASSAY (SUCH AS THE DHCV TEST). IF FOUND REACTIVE, THEY DISCARD; IF FOUND NON-REACTIVE, THEY REPEAT SEROLOGY AND ALSO TEST NON-PROCLEIX PCR. CONCLUSION: THE ROOT CAUSE OF THE FALSE NEGATIVE RESULTS COULD NOT BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. REVIEW OF THE QC RELEASE DATA AND A PREVIOUS EVENTS SEARCH INDICATE THE ULTRIO ELITE DHCV ASSAY IS WORKING AS DESIGNED. NO ADDITIONAL INFORMATION IS EXPECTED, AND THIS IS THE FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666873 PROCLEIX ULTRIO ELITE ASSAY HIV-1/HIV-2/HCV/HBV DEVICE, QHO GRIFOLS DIAGNOSTIC SOLUTIONS INC. 703890 00859882007603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other