BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5

    MDR report key: 888725 · Received October 8, 2004

    Report

    Report Number
    2243471-2004-00004
    Event Type
    Malfunction
    Date Received
    October 8, 2004
    Date of Event
    September 9, 2004
    Report Date
    October 7, 2004
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MTL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE BEEN CONDUCTED AT THE USER SITE AND AT ROCHE MOLECULAR SYSTEMS, INC. THESE INVESTIGATIONS ADDRESSED LABORATORY TECHNIQUE, SAMPLE HANDLING AND STORAGE, ASSAY VARIABILITY AND FREQUENCY OF DISCORDANCY. AS OF THE WRITING OF THIS REPORT, ROCHE HAS NOT CONFIRMED THE REPORT WITH SAMPLES OF KNOWN PEDIGREE. ADDITIONALLY, THE FREQUENCY OF DISCORDANCY HAS NOT BEEN CONFIRMED TO BE DIFFERENT THAN THAT CONTAINED IN THE PRODUCT'S DESIGN HISTORY FILE AND DATA CONTAINED IN THE PRODUCT'S PMA FILING. ROCHE MOLECULAR SYSTEMS, INC. IS CONTINUING TO INVESTIGATE THIS MATTER.

    Description of Event or Problem · 1

    ROCHE MOLECULAR SYSTEMS, INC. RECEIVED A COMPLAINT PERTAINING TO THE COBRAS AMPLICOR HIV-1 MONITOR TEST, V1.5. IN THE COMPLAINT, THE CUSTOMER REPORTED THAT HIV TITERS IN THE STANDARD AND ULTRA SENSITIVE SAMPLE PREPARATIONS DID NOT CORRELATE. REVIEW AND PRELIMINARY INVESTIGATION LEAD TO THE DETERMINATION THAT POTENTIALLY ERRONEOUS RESULTS COULD BE OBTAINED IF THE CUSTOMER REPORT IS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLICOR HIV-1 MONITOR TEST, V1.5 IN VITRO DIAGNOSTIC MTL ROCHE MOLECULAR SYSTEMS, INC. NA F01765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death| O