BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM

    MDR report key: 1586422 · Received January 26, 2010

    Report

    Report Number
    2243471-2010-00002
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 29, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    PMA / PMN Number
    BL 125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME AS THE COMPLAINT INVESTIGATION IS ONGOING. HOWEVER, AS INDICATED WITHIN THE PRODUCT LABELING (CLINICAL PERFORMANCE DATA), OF THE (B)(6) THAT WERE TESTED, (B)(6) OF THESE SPECIMENS WERE (B)(6) WITH THE COBAS(R) TAQSCREEN MPX TEST. THESE DATA INDICATE THAT A CERTAIN PERCENTAGE OF (B)(6) DONOR SAMPLES WILL BE NON-REACTIVE WITH THE COBAS(R) TAQSCREEN MPX TEST. THE CENTERS FOR DISEASE CONTROL AND PREVENTION, (B)(6), PROVIDES THE FOLLOWING REFERENCE FOR INTERPRETATION OF (B)(6). THEREFORE, BASED ON THE CLINICAL PERFORMANCE DATA WITHIN THE PRODUCT LABELING, AND ON THE INTERPRETATION OF (B)(6) PROVIDED BY THE CDC, TESTS RESULTS OF RIBA + AND (B)(6) - CAN BE EXPECTED WHEN TESTING A DONOR/PATIENT SPECIMEN FOR THE (B)(6). CURRENTLY, ROCHE MOLECULAR SYSTEMS IS TRYING TO OBTAIN THE DONOR SAMPLE THAT GENERATED A (B)(6). INVESTIGATION CONCLUSIONS WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DONOR SAMPLE GENERATED A (B)(6) WHEN TESTED WITH THE COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201. THE CUSTOMER INDICATED THAT THE DONOR SAMPLE WAS (B)(6). BOTH THE COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 TEST RESULT AND THE RIBA TEST RESULT WERE REPORTED TO THE BLOOD CENTER. BASED ON BOTH TEST RESULTS, THE BLOOD CENTER DESIGNATED THE DONOR MATERIAL AS (B)(6) AND THE DONOR MATERIAL WAS NOT RELEASED INTO THE BLOOD SUPPLY. IT WAS INDICATED THAT THE DONOR SAMPLE WAS FROM A LIVING DONOR, BUT NO ADDITIONAL INFORMATION ABOUT THE DONOR WAS PROVIDED/AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM ASSAY, NUCLEIC ACID, AMP/DET HIV-1, HCV AND HBV MZP ROCHE MOLECULAR SYSTEMS M11511

    Patients

    Seq Age Sex Outcome Treatment
    1