BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLEIX ULTRIO ELITE ASSAY

    MDR report key: 6491696 · Received April 13, 2017

    Report

    Report Number
    2024800-2017-00012
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    December 30, 2016
    Report Date
    December 28, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    PMA / PMN Number
    BL125652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT IN REGARD TO THE MDR EVENT ASSOCIATED WITH THE PROCLEIX ULTRIO ELITE ASSAY. THIS BLOOD SCREENING PRODUCT IS NOT APPROVED IN US. THE BLA SUBMISSION ((B)(4)) IS CURRENTLY UNDER FDA REVIEW (SUBMITTED ON JANUARY 26, 2017). HOLOGIC, INC. IS REPORTING THIS EVENT DUE TO THE FACT THAT THE ASSAY IS NOW UNDER FDA'S REVIEW AND ALSO BECAUSE A SIMILAR BLOOD SCREENING TEST FROM HOLOGIC (PROCLEIX ULTRIO PLUS ASSAY, (B)(4)) IS LICENSED AND USED FOR DETECTION OF (B)(6) IN HUMAN DONORS IN US. PER HOLOGIC'S RISK ASSESSMENT, THE (B)(6) RESULT MAY HAVE CAUSED A LIFE-THREATENING INJURY. HOWEVER, THIS IS THE ONLY PROBABLE CASE OF TRANSFUSION TRANSMISSION REPORTED FOR THE ULTRIO ELITE ASSAY. THERE HAS BEEN ONLY ONE PREVIOUS TRANSMISSION CASE REPORTED (IN (B)(6) IN 2009) IN (B)(4) DONATIONS OVER A 4 YEAR PERIOD WHICH OCCURRED WITH A SIMILAR ASSAY, THE ULTRIO ASSAY. SINCE THE ULTRIO ELITE ASSAY HAS GREATER SENSITIVITY FOR (B)(6) THAN THE ULTRIO ASSAY, THE PROBABILITY FOR TRANSFUSION TRANSMISSION FOR ULTRIO ELITE IS ESTIMATED TO BE EVEN LESS THAN (B)(4).

    Additional Manufacturer Narrative · 1

    BARCODE READER WAS RETURNED TO AIDE IN SUPPLIER'S INVESTIGATION. SUPPLIER'S INITIAL TESTING DID NOT CONFIRM THE ROOT CAUSE OF THE ISSUE. THE ISSUE WAS TURNED OVER TO THE SUPPLIER'S INTERNAL BAR CODE SPECIALIST FOR IN-DEPTH ANALYSIS. BASED ON THIS SPECIALIST'S INVESTIGATION, THE BARCODE SCANNER WAS RETURNED TO THEIR SUPPLIER FOR FURTHER INVESTIGATION. SUPPLIER INVESTIGATION OF BARCODE SCANNER EXHAUSTED ALL POTENTIAL FAILURE MODES AND WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE WAS A HARDWARE FAILURE. THE ISSUE WAS NOT REPRODUCIBLE. THE MANUFACTURER OF THE BARCODE SCANNER PERFORMED ADDITIONAL INVESTIGATION AND ANALYSIS ON THE SOFTWARE. HOWEVER, THE MANUFACTURER COULD NOT REPRODUCE THE ISSUE AND WAS UNABLE TO DETERMINE THE ROOT CAUSE. ORIGINAL BARCODE LABELS OR A RE-PRINTED VERSIONS FROM THE IBTS LAB WERE NOT PROVIDED BUT ARE NEEDED IN ORDER FOR THE ANALYSIS MIGHT BE EXTENDED TO DEDICATED TESTING WITH THESE LABELS. PER HOLOGIC'S PRELIMINARY RISK ASSESSMENT, CODE 128 BARCODES HAS A GENERALLY ACCEPTED BUT ESTIMATED SUBSTITUTION ERROR RATE BETWEEN 1 IN 2.7 MILLION AND 1 IN 37 MILLION ACCORDING TO A RESEARCH STUDY THAT WAS COMPLETED AND REPORTED IN A REPORT TITLED "PATIENT MISIDENTIFICATIONS CAUSED BY ERRORS IN STANDARD BARCODE TECHNOLOGY". WITH THIS PROBABILITY, IT IS VERY UNLIKELY THAT THE SYSTEM WOULD READ A BARCODE INCORRECTLY AND HAVE IT CORRELATE TO AN ACTUAL PATIENT SAMPLE ID.

    Description of Event or Problem · 1

    ON (B)(6) 2016, (B)(6) LOCATED IN (B)(6) WAS NOTIFIED REGARDING A REPEAT DONOR, WHO WENT TO THE HOSPITAL IN (B)(6) 2016 WITH ACUTE (B)(6) SYMPTOMS. COMMUNICATION OF THE DONOR'S DIAGNOSIS RESULTED IN A LOOK BACK TO BE PERFORMED BY (B)(6), WHICH IDENTIFIED AN IMMUNOCOMPROMISED RECIPIENT WHO WAS TRANSFUSED WITH RBCS FROM THIS DONATION ON (B)(6) 2016 AND WAS (B)(6) (ABBOTT REAL TIME PCR TEST) ON TWO SEPARATE BLOOD SAMPLES BUT (B)(6) FOR (B)(6) SEROLOGICAL MARKERS WHEN TESTED IN (B)(6) 2017. ADDITIONAL INFORMATION: APRIL 10, 2017 - GENOTYPE TESTING UPDATE SAMPLES FROM BOTH DONOR AND RECIPIENT WERE TESTED BY (B)(4). RESULTS SHOW BOTH TO HAVE C1 GENOTYPES. THE (B)(6) DONOR SAMPLE WAS LIKELY EARLY IN THE INFECTION PERIOD AND OF VERY LOW TITER DUE TO THE FACT THAT IT WAS (B)(6) FOR BOTH THE ULTRIO ELITE (NAT) AND SEROLOGY TESTING. LATER IN THE INFECTION PERIOD, PATIENTS WITH (B)(6) WILL TEST (B)(6) WITH A NAT ASSAY AND (B)(6) FOR SEROLOGY BECAUSE THE VIRAL TITER WILL DROP WHILE THE IMMUNE RESPONSE MAY REMAIN DETECTABLE. OVERALL, THE DONOR SAMPLE WAS TESTED A TOTAL OF 3 TIMES [TWICE WITH THE ULTRIO ELITE MULTIPLEX ASSAY ((B)(6) IN BOTH INSTANCES) AND ONCE WITH THE DISCRIMINATORY (B)(6) ASSAY ((B)(6))] AND WAS (B)(6) IN 1 OF 3 ULTRIO ELITE TESTS (33%). THE VALIDATION STUDIES IN THE ULTRIO ELITE PACKAGE INSERT (PN: 503049) SHOW (B)(6) WHO (WORLD HEALTH ORGANIZATION 97/750) PANELS ARE LESS THAN 100% (B)(6) IN BOTH THE ULTRIO ELITE AND (B)(6) ASSAYS AT VIRAL CONCENTRATIONS LESS THAN 5 IU/ML. AT 0.56 IU/ML, BOTH THE ULTRIO ELITE AND (B)(6) ASSAYS HAD A REACTIVITY OF 34%. THIS IS CONSISTENT WITH THE DONOR SAMPLE HAVING A TITER THAT WAS BELOW THE CLAIMED SENSITIVITY OF THE PROCLEIX ULTRIO ELITE ASSAY.

    Description of Event or Problem · 1

    GRIFOLS REPORTED THEIR CUSTOMER (B)(6) HAD A SAMPLE ID BARCODE MISREAD ON THE PANTHER. (B)(4). GRIFOLS PERFORMED AN INITIAL REVIEW OF THE LOGS AND DID NOT FIND ANY UNEXPECTED SW BEHAVIOR. PANTHER SUPPLIER WAS NOTIFIED AND FURTHER INVESTIGATION IS ONGOING BY HOLOGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272158 PROCLEIX ULTRIO ELITE ASSAY IN VITRO DIAGNOSTICS LSL HOLOGIC, INC. 131154; 146182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R