BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEIX ULTRIO ASSAY

    MDR report key: 7076964 · Received December 1, 2017

    Report

    Report Number
    2032600-2017-00001
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    July 31, 2017
    Report Date
    July 21, 2020
    Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Product Code
    QHO
    PMA / PMN Number
    BL125113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    COMPLAINT WAS RECEIVED BY GRIFOLS FROM EFS (FRENCH BLOOD ESTABLISHMENT) LOCATED IN EPAGNY-METZ-TESSY, FRANCE ON (B)(6)2017 REGARDING A CASE OF A FALSE NEGATIVE RESULT GENERATED DURING (B)(6) 2017 DRAW TESTING, WHICH WAS SCREENED NONREACTIVE USING THE PROCLEIX ULTRIO ASSAY ON THE TIGRIS SYSTEM. BASED ON THE REPORTED INCIDENT AND AVAILABLE INFORMATION TO DATE, THE DONOR WAS POSITIVE FOR HIV-1 IN (B)(6) 2017 (APPROXIMATE). NO INFORMATION REGARDING RECIPIENT(S) OF THE MARCH DONATION OR THE HEALTH OUTCOME OF THESE RECIPIENT(S) HAS BEEN PROVIDED TO GRIFOLS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO ACQUIRE THIS INFORMATION, BUT THE REQUESTS FOR INFORMATION HAVE BEEN DENIED. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THE PROCLEIX ULTRIO ASSAY. THE INVESTIGATION AND DATA SHOW THAT THE ASSAY IS PERFORMING AS INTENDED. (B)(6)2020: THIS REPORT IS AN UPDATE TO THE PREVIOUS REPORT, 2032600-2017-00001 FOLLOW-UP 2, THAT WAS MISSING UPDATED INFORMATION IN SECTION B5. IT IS BEING RESUBMITTED AS 2032600-2017-00001 FOLLOW-UP 3 WITH UPDATED NARRATIVE IN SECTION B5 .

    Description of Event or Problem · 0

    COMPLAINT WAS RECEIVED BY GRIFOLS FROM EFS (FRENCH BLOOD ESTABLISHMENT) LOCATED IN (B)(6) , FRANCE ON 28SEP2017 REGARDING A CASE OF A FALSE NEGATIVE RESULT GENERATED DURING (B)(6) 2017 DRAW TESTING, WHICH WAS SCREENED NONREACTIVE USING THE PROCLEIX ULTRIO ASSAY ON THE TIGRIS SYSTEM. BASED ON THE REPORTED INCIDENT AND AVAILABLE INFORMATION TO DATE, THE DONOR WAS POSITIVE FOR HIV-1 IN (B)(6) 2017 (APPROXIMATE). THERE IS NO ADDITIONAL INFORMATION OF POTENTIAL TRANSMISSION-TRANSFUSION DUE TO THIS INCIDENT. GRIFOLS IS WAITING FOR INFORMATION ABOUT THE STATUS OF THE RECIPIENTS (IF ANY) FROM THE (B)(6) 2017 DONATION. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THE PROCLEIX ULTRIO ASSAY. THE INVESTIGATION AND DATA SHOW THAT THE ASSAY IS PERFORMING AS INTENDED. 07/21/2020: THIS REPORT IS A RESUBMISSION OF A PREVIOUS REPORT, 2032600-2017-00002 FOLLOW-UP 1, THAT WAS INADVERTANTLY SUBMITTED AS THE WRONG MDR NUMBER ON 06-DEC-17. IT IS BEING RESUBMITTED AS 2032600-2017-00001 FOLLOW-UP 1 PER REQUEST BY FDA ON 16-JUL-20.

    Description of Event or Problem · 0

    COMPLAINT WAS RECEIVED BY GRIFOLS FROM EFS (FRENCH BLOOD ESTABLISHMENT) LOCATED IN (B)(6) ON (B)(6) 2017 REGARDING A CASE OF A FALSE NEGATIVE RESULT GENERATED DURING (B)(6) 2017 DRAW TESTING, WHICH WAS SCREENED NONREACTIVE USING THE PROCLEIX ULTRIO ASSAY ON THE TIGRIS SYSTEM. BASED ON THE REPORTED INCIDENT AND AVAILABLE INFORMATION TO DATE, THE DONOR WAS POSITIVE FOR HIV-1 IN (B)(6) 2017 (APPROXIMATE). THERE IS NO ADDITIONAL INFORMATION OF POTENTIAL TRANSMISSION-TRANSFUSION DUE TO THIS INCIDENT. GRIFOLS IS WAITING FOR INFORMATION ABOUT THE STATUS OF THE RECIPIENTS (IF ANY) FROM THE (B)(6) 2017 DONATION. NO CORRECTIVE ACTIONS ARE REQUIRED FOR THE PROCLEIX ULTRIO ASSAY. THE INVESTIGATION AND DATA SHOW THAT THE ASSAY IS PERFORMING AS INTENDED.(B)(6) 2020: THIS REPORT IS A RESUBMISSION OF A PREVIOUS REPORT, 2032600-2017-00002 FOLLOW-UP 2, THAT WAS INADVERTANTLY SUBMITTED AS THE WRONG MDR NUMBER ON (B)(6) 2017. IT IS BEING RESUBMITTED AS 2032600-2017-00001 FOLLOW-UP 2 PER REQUEST BY FDA ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR EVENT WAS SUBMITTED UNDER REPORT NUMBER 2024800-2017-00020 ON OCTOBER 27, 2017. DUE TO THE DUPLICATE REPORT NUMBER, THIS EMDR SUBMISSION FAILED AND IS BEING RESUBMITTED UNDER A DIFFERENT (2032600-2017-00001) REPORT NUMBER AS RECOMMENDED BY CDRH EMDR CONSUMER SAFETY OFFICER.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED BY GRIFOLS FROM (B)(6) LOCATED IN (B)(6) ON 28SEP2017 REGARDING A CASE OF A (B)(6) RESULT GENERATED DURING (B)(6) 2017 DRAW TESTING, WHICH WAS SCREENED (B)(6) USING THE PROCLEIX ULTRIO ASSAY ON THE TIGRIS SYSTEM. BASED ON THE REPORTED INCIDENT AND AVAILABLE INFORMATION TO DATE, THE DONOR WAS (B)(6) IN (B)(6) 2017 (APPROXIMATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853541 PROCLEIX ULTRIO ASSAY HIV-1, HCV AND/OR HBV IVD DEVICE QHO GRIFOLS DIAGNOSTIC SOLUTIONS INC. 176126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other