BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQSCREEN MPX TEST

    MDR report key: 2025220 · Received March 21, 2011

    Report

    Report Number
    2243471-2011-00039
    Date Received
    March 21, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ROCHE MOLEUCLAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BL125255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE PERFORMED ACCORDING TO SPECIFICATION, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE DONOR DONATED THREE TIMES AND GENERATED (B)(6) SEROLOGY RESULTS FOR ALL THREE DONATIONS. NO DONOR UNITS WERE RELEASED FROM ANY OF THE DONATIONS. INVESTIGATIVE VIRAL LOAD TESTING OF THE DONOR SAMPLE IN QUESTION (FROM THE SECOND DONATION) WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV-1 V2.0 TEST GENERATED A RESULT OF TARGET NOT DETECTED. THIS RESULT IS NOT NECESSARILY UNEXPECTED BASED ON THE (B)(6) COBAS TAQSCREEN MPX RESULTS AND (B)(6) IN-HOUSE PCR TEST RESULTS GENERATED AT THE CUSTOMER SITE. DESPITE SEVERAL ATTEMPTS TO OBTAIN HIV-1 SEQUENCE FROM THE RETURNED SAMPLE FROM THE SECOND DONATION, NO VIRUS SEQUENCE WAS OBTAINED. (B)(4). NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED. (B)(4). THE CUSTOMER'S ALLEGATION WAS SPECIFIC TO A DONOR SAMPLE FROM ONE DONOR AND NOT SPECIFIC TO THE COMPLAINT KIT BATCH. THE CONTROLS AND OTHER DONOR SAMPLES INCLUDED IN THE RUNS GENERATED EXPECTED AND VALID RESULTS. THE CUSTOMER INDICATED THAT THE COMPLAINT KIT BATCHES WERE USED AT THE CUSTOMER SITE WITHOUT OBSERVING ADDITIONAL ISSUES. (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: PRODUCT CODE MZF WAS SELECTED AS THE CUSTOMER ALLEGATION INDICATES THAT THE DONATION WAS DISCREPANT FOR (B)(6). THERE IS NO PRODUCT CODE FOR AN ASSAY THAT SIMULTANEOUSLY DETECTS FOR (B)(6). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) REPORTED THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS TAQSCREEN MPX TEST WHEN COMPARED TO SEROLOGY RESULTS. SPECIFICALLY, THE CUSTOMER INDICATED THAT THE DONATION WAS NON-REACTIVE WITH THE COBAS TAQSCREEN MPX TEST AND SEROLOGY POSITIVE FOR (B)(6). THE DONATION WAS NOT RELEASED DUE TO THE SEROLOGY (B)(6) TEST RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST TEST, NUCLEIC ACID AMP / DET FOR HIV, HCV, HBV MZF ROCHE MOLEUCLAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1