BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS® TAQSCREEN MPX TEST

    MDR report key: 1834300 · Received September 14, 2010

    Report

    Report Number
    2243471-2010-00038
    Date Received
    September 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BL 125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT.NOTE: PRODUCT CODE MZF WAS SELECTED AS NO ALTERNATIVE / MORE APPLICABLE CODE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTED / ADDITIONAL DATA: UPDATED TO INCLUDE BL NUMBER. METHODS, RESULTS, AND CONCLUSIONS WERE UPDATED TO REFLECT THE OUTCOME OF THE COMPLAINT INVESTIGATION. DUE TO THE (B)(6) RESULTS, THE DONOR WAS CONSIDERED (B)(6) AND WAS NOT RELEASED. ALTHOUGH REQUESTED, NO SAMPLE WAS AVAILABLE FOR ANALYSIS BY ROCHE. ADDITIONALLY, INFORMATION REGARDING THE PATIENT STATUS WAS REQUESTED, BUT NOT PROVIDED BY THE CUSTOMER. THE (B)(6) TEST IS A QUALITATIVE IN VITRO TEST FOR THE DIRECT DETECTION OF (B)(6). THE TEST IS INTENDED AS A DONOR SCREENING TEST TO DETECTED (B)(6) IN PLASMA SPECIMENS FROM INDIVIDUAL BLOOD DONORS, INCLUDING DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS, SOURCE PLASMA, AND OTHER LIVING DONORS. THIS TEST IS ALSO INTENDED FOR USE TO SCREEN INDIVIDUAL ORGAN AND TISSUE DONORS WHEN SPECIMENS ARE OBTAINED WHILE THE DONOR'S HEART IS STILL BEATING, AND IN BLOOD SPECIMENS FROM CADAVERIC ORGAN AND TISSUE DONORS. FOR DONATIONS OF WHOLE BLOOD AND BLOOD COMPONENTS, PLASMA SPECIMENS MAY BE TESTED INDIVIDUALLY OR IN POOLS COMPRISED OF EQUAL ALIQUOTS OF INDIVIDUAL SPECIMENS IN CONJUNCTION WITH SEROLOGY TESTS FOR (B)(6). THIS TEST IS NOT INTENDED FOR USE AS AN AID IN DIAGNOSIS. THE INVESTIGATION INTO THIS ISSUE DETERMINED THE FOLLOWING: THROUGH VARIOUS PUBLICATIONS, IT WAS NOTED THAT IT IS POSSIBLE FOR A (B)(6) SITUATION TO ARISE, FOR EXAMPLE, WHEN THE PATIENT IS A CHRONIC CARRIER OR HAS AN UNDETECTABLE VIRAL LOAD DUE TO ANTIVIRAL THERAPY. A (B)(6) RESULT WITH THE (B)(6) TEST AND A (B)(6) RESULT WITH A COMPETITOR (B)(6) ON A FOLLOW-UP DONATION (WHICH WAS NOT TESTED WITH THE MPX TEST) CAN BE EXPECTED DUE TO THE NATURE OF THE DONOR SPECIMEN. FOR EXAMPLE, DUE TO A LOW VIRAL LOAD LEADING TO SAMPLING INCONSISTENCY OR SAMPLE SEQUENCE MISMATCHES. AS SPECIFIED WITHIN THE PRODUCT LABELING: "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOME COVERED BY THE COBAS TAQSCREEN MPX TEST PRIMERS AND/OR PROBES MAY RESULT IN THE FAILURE TO DETECT A VIRUS." "DETECTION OF (B)(6) IS DEPENDANT ON THE NUMBER OF VIRUS PARTICLES PRESENT IN THE SPECIMEN AND MAY BE AFFECTED BY SPECIMEN COLLECTIONS METHODS, PATIENT FACTORS (I.E., AGE, PRESENCE OF SYMPTOMS), AND/OR STAGE OF INFECTION AND POOL SIZE." NEITHER OF THESE SCENARIOS COULD BE FURTHER EXPLORED AS, ALTHOUGH REQUESTED, THE DONATION WAS NOT AVAILABLE TO ROCHE. THE COMPLAINT KIT LOT MET SPECIFICATIONS DURING INVESTIGATIVE TESTING. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A MALFUNCTION / NON-CONFORMANCE WITH THE COBAS TAQSCREEN MPX TEST. SERIOUS INJURY / DEATH WERE NOT IDENTIFIED AS THE DONATION WAS REJECTED DUE THE (B)(6) SEROLOGY AND COMPETITORS (B)(6) TESTING; AS SPECIFIED WITHIN THE PRODUCT LABELING, THE TEST SHOULD BE USED IN CONJUNCTION WITH SEROLOGY TESTS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(4) REPORTED THAT, FOR THE COBAS TAQSCREEN MPX TEST, A SAMPLE RESULT TESTED NEGATIVE FOR (B)(4) BUT THE SEROLOGY RESULT FOR THE SAME SAMPLE WAS POSITIVE FOR (B)(4). A SECOND SAMPLE WAS PROCESSED AT THE SAME SITE USING TRANSCRIPTION-MEDIATED AMPLIFICATION TEST (B)(4) AND THE RESULT WAS POSITIVE FOR (B)(6). THIS SAME SAMPLE WAS TESTED BY SEROLOGY AND WAS (B)(6) POSITIVE AND (B)(6). THE CUSTOMER DID NOT PROCESS THIS SECOND SAMPLE WITH MPX. DUE TO THE NAT AND SEROLOGY DISCREPANT RESULTS, THE BLOOD WAS NOT RELEASED INTO THE BLOOD SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS® TAQSCREEN MPX TEST HIV, HCV, HBV NUCLEIC ACID BLOOD SCREENING TEST, PRODUCT CODE: MZF MZF ROCHE MOLECULAR SYSTEMS M14697

    Patients

    Seq Age Sex Outcome Treatment
    1