BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 1.0

    MDR report key: 3122576 · Received May 21, 2013

    Report

    Report Number
    2243471-2013-00011
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULT CODE DEVICE PERFORMED ACCORDING TO SPECIFICATION. CONCLUSION CODE NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATIONS. THE CUSTOMER ALLEGED THAT A SAMPLE FROM A KNOWN (B)(6) PATIENT GENERATED A TARGET NOT DETECTED (TND) (B)(6) WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(6) TEST. THE PATIENT WAS (B)(6) AND POSITIVE FOR WESTERN BLOT. WHEN THE SAMPLE WAS TESTED WITH THE CAP/CTM (B)(6) TEST, THE TEST GENERATED A DETECTABLE VIRAL LOAD. HOWEVER, THE EXACT VIRAL TITER WAS NOT PROVIDED. THE PATIENT SAMPLE WAS SENT FOR SEQUENCING ANALYSIS. THE SEQUENCE OBTAINED FOR THE LTR REGION MATCHES PERFECTLY WITH THE PRIMERS AND PROBE SEQUENCES FOR THE CAP/CTM (B)(6) TEST. WHEN ALIGNED TO THE GAG PRIMERS AND PROBE USED IN THE CAP/CTM (B)(6) AND CAP/CTM (B)(6) TESTS, THERE ARE MISMATCHES TO BOTH THE UPSTREAM AND DOWNSTREAM PRIMER REGIONS. THE DOWNSTREAM PRIMER HAS AN N-3 MISMATCH WHICH HAS BEEN SHOWN TO AFFECT TARGET AMPLIFICATION. THEREFORE, SINCE THE CAP/CTM (B)(6) HAS ONLY THE GAG REGION AND THE CAP/CTM (B)(6) TEST HAS BOTH THE GAG AND LTR REGIONS, THIS COULD EXPLAIN THE DIFFERENCE IN PERFORMANCE SEEN IN THE TWO ASSAYS WITH THIS SAMPLE. THE CAP/CTM (B)(6) US-IVD PACKAGE INSERT STATES, IN THE PROCEDURAL LIMITATIONS SECTION, "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGION OF THE VIRAL GENOME COVERED BY THE COBAS AMPLIPREP / COBAS TAQMAN (B)(6) TEST PRIMERS AND / OR PROBE MAY RESULT IN THE UNDERQUANTITATION OF OR FAILURE TO DETECT THE VIRUS." (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN THE US FILED A COMPLAINT ALLEGING THAT A SAMPLE FROM A KNOWN (B)(6) PATIENT GENERATED A (B)(6) RESULT WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV V1 TEST. THE PATIENT WAS (B)(6) AND WESTERN BLOT (B)(6). WHEN THE SAMPLE WAS TESTED WITH THE CAP / CTM HIV V2 TEST, THE CUSTOMER STATED THAT IT GENERATED A DETECTABLE VIRAL LOAD. HOWEVER, THE EXACT VIRAL TITER RESULT WAS NOT PROVIDED. THE DATES OF TESTING WERE NOT PROVIDED. THE PATIENT¿S CONDITION AND TREATMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225210 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 1.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1