BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6792675 · Received August 14, 2017

    Report

    Report Number
    2243471-2017-00021
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 9, 2017
    Report Date
    November 20, 2017
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC
    Product Code
    MZF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6), ALLEGED THAT RESULT DISCREPANCIES WERE GENERATED FOR A DONOR SAMPLE WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM BASED ON SEROLOGY AND/OR RETEST RESULTS WITH THE COBAS® TAQSCREEN MPX TEST. THE SAMPLE WAS FROM A BLOOD DONOR AND THE DISCREPANCIES WERE OBSERVED DURING ROUTINE SCREENING. THIS DONOR IS SUSPECTED TO BE HIV-1 POSITIVE WITH A VIRAL LOAD OF 5.2 LOG10 IU/ML, ACCORDING TO RESULTS GENERATED WITH QIAGEN ARTUS HIV RT-PCR TEST. THIS SAMPLE WAS ALSO TESTED 3 TIMES WITH THE COBAS TAQSCREEN MPXV2.0 TEST AND GENERATED CONSISTENT NON-REACTIVE RESULTS FOR HIV, ONCE WITH LOT 219650 AND TWICE WITH LOT 230804. THE DONOR SAMPLE WAS RETURNED FOR FURTHER INVESTIGATION, WHICH INCLUDED TESTING WITH THE COMPLAINT COBAS TAQSCREEN MPX TEST V2.0, THE ABBOTT REALTIME HIV-1 ASSAY, THE ROCHE COBAS MPX TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS, THE ROCHE COBAS HIV-1 TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS, AND SEQUENCE ANALYSIS. THE FOLLOWING RESULTS WERE GENERATED: COBAS TAQSCREEN MPX TEST, V2.0: 2 REPLICATES WERE TESTED AND EACH GENERATED NON-REACTIVE HIV RESULTS. ABBOTT REALTIME HIV-1 ASSAY: 2 REPLICATES WERE TESTED AND GENERATED RESULTS OF 5.4 LOG10 IU/ML. COBAS MPX TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS: 2 REPLICATES WERE TESTED AND GENERATED HIV REACTIVE RESULTS. COBAS HIV-1 FOR USE ON THE COBAS 6800/8800 SYSTEMS: 2 REPLICATES WERE TESTED AND GENERATED A MEAN HIV-1 TITER OF 4.6 LOG10 CP/ML. HIV-1 SEQUENCES WERE OBTAINED FOR THIS DONOR SAMPLE. THE OBTAINED SEQUENCES WERE ANALYZED FOR ANY MUTATIONS TO PRIMERS AND PROBES ASSOCIATED WITH THE COMPLAINT COBAS TAQSCREEN MPX TEST, V2.0. TWO POINT MUTATIONS NEAR THE 3¿ END OF A PRIMER FOR THE LTR TARGET REGION WERE IDENTIFIED. THIS IS THE FIRST TIME THIS PARTICULAR MISMATCH PATTERN HAS BEEN SEEN IN THE ROCHE IN-HOUSE OR THE PUBLIC DATABASE. BIOINFORMATICS TOOLS WERE USED TO ASSESS THESE MISMATCHES, WHICH WERE INDICATED TO BE LIKELY TO IMPACT ASSAY PERFORMANCE. IT WAS ALSO NOTED THAT THE SEQUENCE OBTAINED FOR THIS TARGET REGION HAS A 20 BASE PAIR DELETION BETWEEN THE FORWARD PRIMER AND THE PROBE, WHICH MAY HAVE CONTRIBUTED TO THE POSITION OF THE MISMATCHES OR MIGHT HAVE SOME UNDETERMINED IMPACT ON THE ASSAY. THIS MISMATCH PATTERN COULD POTENTIALLY AFFECT THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0. THE INSTRUCTIONS FOR USE INDICATES THAT THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF A VIRAL GENOME COVERED BY THE COBAS® TAQSCREEN MPX TEST, V2.0 PRIMERS AND/OR PROBE MAY RESULT IN FAILURE TO DETECT A VIRUS. THE TOTALITY OF RESULTS FOR THIS DONOR SAMPLE INDICATE THAT THIS SAMPLE CONTAINS A NOVEL SEQUENCE OF HIV-1 WITH SPECIFIC MUTATIONS THAT CONTRIBUTE TO THE OBSERVED HIV NON-REACTIVE RESULTS GENERATED WITH THE COBAS TAQSCREEN MPX TEST V2.0. ADDITIONALLY, THE COMPLAINT KIT LOTS USED AT THE SITE TO TEST THE DONOR (LOTS 219650 AND 230804) WERE TESTED AND RESULTS MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY ON-GOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW UP REPORT. THE UDI FOR COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD IS (B)(4). THE CORRESPONDING US KIT MATERIAL NUMBER IS (B)(4). IN INITIAL REPORTER (FACILITY NAME), THE NAME OF THE FACILITY IS (B)(6). DUE TO CHARACTER LIMITS IN THE FORM, THE NAME OF THE FACILITY WAS TRUNCATED TO PRATHAMA BLOOD CENTRE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6), ADVANCED TRANSFUSION MEDICINE RESEARCH FOUNDATION PRATHAMA BLOOD CENTRE, ALLEGED THAT RESULT DISCREPANCIES WERE GENERATED FOR 2 DONOR SAMPLES WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM BASED ON SEROLOGY AND/OR RETEST RESULTS WITH THE COBAS® TAQSCREEN MPX TEST. THE SAMPLES WERE FROM BLOOD DONORS AND THE DISCREPANCIES WERE OBSERVED DURING ROUTINE SCREENING. THIS DONOR (DONOR #2) IS SUSPECTED TO BE (B)(6) WITH A VIRAL LOAD OF (B)(6), ACCORDING TO RESULTS GENERATED WITH QIAGEN ARTUS(B)(6) RT-PCR TEST. THIS SAMPLE WAS ALSO TESTED 3 TIMES WITH THE COBAS® TAQSCREEN MPXV2.0 TEST AND GENERATED CONSISTENT (B)(6), ONCE WITH LOT 219650 AND TWICE WITH LOT 230804. THIS MDR ADDRESSES DONOR #2. A SEPARATE MDR WILL BE FILED TO ADDRESS THE OTHER DONOR ALLEGED (DONOR #1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571720 NA NA MZF ROCHE MOLECULAR SYSTEMS, INC NA 219650

    Patients

    Seq Age Sex Outcome Treatment
    1