BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HBC IMMUNOASSAY

    MDR report key: 6221060 · Received January 4, 2017

    Report

    Report Number
    1823260-2017-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 12, 2016
    Report Date
    June 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    P100031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). FACILITY NAME - THE FULL FACILITY NAME WAS PROVIDED AS "(B)(6)". PHONE NUMBER WAS PROVIDED AS "(B)(6)".

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A RESIDENT OF (B)(6) AND IS ONLY SEEN IN (B)(6) EVERY 3-4 MONTHS. THE FIRST CONTACT OF THE PATIENT WITH THE ANALYZING CLINIC WAS ON (B)(6) 2015. THE PATIENT RECEIVED AN ORGAN TRANSPLANT (KMT) ON (B)(6) 2015. THE DONOR IS AN OVERSEAS DONOR WITH UNREMARKABLE MEDICAL HISTORY AND "AML". THE PATIENT WAS NOT TAKING IMMUNOSUPPRESSIVE DRUGS SINCE THE BEGINNING OF 2016. THE CUSTOMER STATED THE PATIENT WAS, "CLINICALLY NOT SUSPICIOUS SINCE THEN." ON (B)(6) 2015, THE FOLLOWING VALUES WERE OBTAINED FROM THE PATIENT AT THE CUSTOMER SITE (BEFORE KMT): NEGATIVE FOR HBSAG, NEGATIVE FOR ANTI-HBC, < 10 IU/L FOR ANTI-HBS, NEGATIVE FOR HBE ANTIGEN, AND NEGATIVE FOR ANTI-HBE. ON (B)(6) 2016, THE FOLLOWING VALUES WERE OBTAINED FROM THE PATIENT AT THE CUSTOMER SITE: NEGATIVE (0.42 COI) FOR HBSAG, NEGATIVE (1.78 COI) FOR ANTI-HBC, < 10 IU/L FOR ANTI-HBS, NEGATIVE (0.08) FOR ANTI-HBC IGM, AND 100 FOR HBV-NAAT. NO UNITS OF MEASURE WERE PROVIDED FOR THE NUMERICAL VALUES OBTAINED FOR THE ANTI-HBC IGM AND HBV-NAAT TESTS. THE PATIENT HAD NO INTERVENTION AFTER THE ORGAN TRANSPLANTATION (KMT) UNTIL THE INITIAL DIAGNOSIS IN NOVEMBER 2016, WHICH COULD EXPLAIN AN INFECTION. IN THE CLINIC ALWAYS PERFORMS SEROLOGICAL TESTING BEFORE TRANSPLANTATION (KMT). THERE WAS NO INDICATION OF ACUTE INFECTION IN (B)(6) 2016. THE PATIENT SAMPLE FROM (B)(6)2016 HAD AN ANTI-HBS RESULT OF <10 IU/L AND A NEGATIVE ANTI-HBC IGM RESULT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND MEASURED (B)(6) 2017. THIS SAMPLE HAD THE FOLLOWING RESULTS: NEGATIVE (0.44 COI) FOR HBSAG, POSITIVE (0.203 COI) FOR ANTI-HBC, 24+ IU/L FOR ANTI-HBS, NEGATIVE (0.245) FOR ANTI-HBC IGM, AND NEGATIVE FOR HBV-NAAT. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THIS SAMPLE. THE CUSTOMER ASSUMES THAT THE PATIENT UNDERWENT A SEROCONVERSION. IN ADDITION, THE CUSTOMER REPORTED A NEGATIVE RESULT FOR QUALITATIVE HBV DNA ANALYSIS. ONLY THE MENTIONED TESTING AND PCR TESTING WERE CARRIED OUT UPON PRESENTATION OF THE PATIENT IN 2017. NO FURTHER ACTIONS WERE TAKEN WITH THE PATIENT. HBSAG REAGENT LOT NUMBER 183332 WAS IN USE DURING TIME OF TESTING ON (B)(6) 2017. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. FIVE (5) SAMPLES OF THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE NEGATIVE HBSAG RESULTS OBTAINED BY THE CUSTOMER WERE DUPLICATED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED BASED ON THE OBTAINED RESULTS. ANTI-HBC RESULTS WERE REACTIVE FOR ALL 5 SAMPLES. MEDWATCH FIELD A2 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE TESTED WITH A PCR METHOD FOR (B)(6) AND WERE (B)(6). THE RESULTS OBTAINED BY THE CUSTOMER WITH THE SAMPLES WERE REPRODUCED AND MATCHED RESULTS FROM A COMPETITOR SYSTEM. SINCE (B)(6) ARE (B)(6) AND (B)(6) ARE (B)(6), A SEROCONVERSION IS MOST LIKELY. THE DISCREPANCIES SEEN WITH RESULTS FROM (B)(6) 2016 COULD NOT BE INVESTIGATED SINCE ONLY RECENT MATERIAL (AFTER SEROCONVERSION) IS AVAILABLE. FOR THE RECENT SAMPLE MATERIAL, NO DISCREPANT RESULTS WERE SEEN. THE REAGENT PERFORMED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A SAMPLE FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. NO PRODUCT PROBLEM WAS FOUND AND NO GENERAL REAGENT ISSUE WAS FOUND.

    Additional Manufacturer Narrative · 1

    FOR FURTHER INVESTIGATION, THE PATIENT SAMPLES WERE TESTED ON AN ARCHITECT ANALYZER. (B)(6) WAS (B)(6) ON THE ARCHITECT ANALYZER. (B)(6) WERE (B)(6) ON THE ARCHITECT ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS (B)(6) IMMUNOASSAY (B)(6) AND THE ELECSYS (B)(6) IMMUNOASSAY ((B)(6)) ON A COBAS 8000 E 602 MODULE (E602). THIS MEDWATCH WILL COVER THE (B)(6) ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO (B)(6) ASSAY. THE SAMPLE HAD A (B)(6) RESULT WHEN TESTED ON THE E602 ANALYZER. THE SAMPLE WAS ALSO INITIALLY FOUND TO BE (B)(6) FOR (B)(6) ON THE E602 ANALYZER. PCR TESTING OF THE PATIENT WAS ACCIDENTALLY REQUESTED FOR THE SAMPLE AND THE PCR TEST FOUND AN (B)(6) VIRAL LOAD OF 100 IU/ML. THE SAMPLE WAS SEQUENCED PARTIALLY AND THIS RESULTED IN INVOLVEMENT OF THE GENOTYPE D WITH THE FOLLOWING MUTATIONS: P120T, R122K, S132F, 133I, D144E. THE CUSTOMER WAS CONCERNED THAT THERE IS POTENTIAL RISK TO THE PATIENT DUE TO THE (B)(6) RESULT ON THE E602 ANALYZER. THE PATIENT IS UNDER IMMUNE SUPPRESSION AND IT IS UNCLEAR WHETHER AN (B)(6) INFECTION WAS ALREADY PRESENT BEFORE THE TRANSPLANTATION. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5071 ELECSYS ANTI-HBC IMMUNOASSAY TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR