BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 2235583 · Received September 6, 2011

    Report

    Report Number
    2243471-2011-00079
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 4, 2011
    Report Date
    December 5, 2011
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    PMA / PMN Number
    BP125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED THE SAMPLE IN QUESTION FOR INVESTIGATION. THE CUSTOMER ALLEGED THAT (B)(6) RESULTS WERE GENERATED FOR THE COBAS TAQSCREEN MPX TEST AND (B)(6) SEROLOGY RESULTS WERE GENERATED FOR (B)(6) (SEROLOGY TEST USED IS UNKNOWN). THE BLOOD BAG WAS BLOCKED BASED ON THE SEROLOGY RESULTS. SEQUENCING ANALYSIS OF THE SAMPLE WAS PERFORMED. DESPITE SEVERAL ATTEMPTS TO OBTAIN (B)(6) SEQUENCES FROM THE SAMPLE, NO VIRAL SEQUENCES WERE OBTAINED. THE LACK OF (B)(6) SEQUENCE DOES NOT NECESSARILY MEAN THAT NO (B)(6) VIRUS IS PRESENT IN THE SAMPLE. THE LACK OF SEQUENCE INFORMATION COULD BE DUE TO SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR SEQUENCING AND/ OR DUE TO LOW VIRAL TITERS. THE LACK OF (B)(6) SEQUENCE COULD ALSO INDICATE VIRAL CLEARANCE. NO SAMPLE MATERIAL REMAINS TO PERFORM ANY FURTHER INVESTIGATION. ACCORDING TO THE COBAS TAQSCREEN MPX TEST FOR USE ON THE COBAS S 20 SYSTEM PACKAGE INSERT, "PLASMA FROM ALL DONORS MAY BE SCREENED AS INDIVIDUAL SPECIMENS. 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)." THEREFORE, THE REPORTED RESULTS FOR DONOR SAMPLES ARE A COMBINATION OF BOTH SEROLOGY AND MPX TEST RESULTS. THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT PROVIDES THE LIMIT OF DETECTION (LOD) OF THE ASSAY FOR (B)(6) DURING INDIVIDUAL TESTING OF THE SAMPLES OF 11 IU/ML. IF THE SAMPLES CONTAINED (B)(6) TITERS BELOW OR CLOSE TO THE LOD OF THE MPX TEST, THEN IT IS POSSIBLE THAT THE SAMPLES WOULD GENERATE A (B)(6) RESULT. THIS, HOWEVER, CANNOT BE CONFIRMED, AS THERE WAS INSUFFICIENT REMAINING SAMPLE MATERIAL REMAINING TO DETERMINE. (B)(4).

    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 1: PRODUCT CODE MZP WAS SELECTED AS NO ALTERNATIVE / MORE APPLICABLE CODE IS AVAILABLE. NOTE 2: THIS ISSUE IS BEING REPORTED AGAINST THE CE-IVD VERSION OF THE COBAS TAQSCREEN MPX TEST AS THIS IS THE KIT THAT WAS IDENTIFIED WITHIN THE CUSTOMER COMPLAINT. THE US-IVD VERSION OF THE COBAS TAQSCREEN MPX TEST IS CATALOG NUMBER 04584252190. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) HAS ALLEGED THAT DISCREPANT TEST RESULTS WERE GENERATED FOR TWO PATIENT SAMPLES (BEING REPORTED THROUGH MDR 2243471-2011-00079 AND -00080) WITH THE COBAS TAQSCREEN MPX TEST WHEN COMPARED TO AN UNKNOWN SEROLOGY TEST. SPECIFICALLY, THE CUSTOMER INDICATED THAT THE TWO PATIENT SAMPLES GENERATED (B)(6) SEROLOGY RESULTS WITH AN UNKNOWN TEST AND (B)(6) NAT RESULTS USING THE COBAS TAQSCREEN MPX TEST. THE CUSTOMER INDICATED THAT BOTH SAMPLES CAME FROM THE SAME DONOR AND WERE COLLECTED ON TWO DIFFERENT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS MZP ROCHE MOLECULAR SYSTEMS 034303

    Patients

    Seq Age Sex Outcome Treatment
    1