BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS 4800 HPV TEST, CE-IVD

    MDR report key: 2387032 · Received December 22, 2011

    Report

    Report Number
    2243471-2011-00106
    Date Received
    December 22, 2011
    Date of Event
    December 1, 2011
    Report Date
    March 22, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: YES. RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. UPON INVESTIGATION, THERE WAS NO INTERNAL NONCONFORMANCES GENERATED FOR KIT BATCH P08961. QC RELEASE DATA FOR THE KIT BATCHES MET SPECIFICATIONS. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. RETAIN KITS FOR THOSE KIT BATCHES USED DURING THE 2011 EVALUATIONS MET SPECIFICATIONS WHEN TESTED IN HOUSE. RETAIN TESTING WAS NOT PERFORMED FOR THE KIT COMBINATION USED IN THE 2009 EVALUATION AS THE MAIN KIT WAS EXPIRED AT THE TIME TESTING WOULD HAVE OCCURRED. THE CUSTOMER DID PROVIDE PATIENT SAMPLES, WHICH WERE TESTED FOR CUSTOMER SATISFACTION PURPOSE; NO CONCLUSIONS COULD BE DRAWN FROM THE DATA GENERATED AS THE SAMPLES WERE CONSIDERED OFF-LABEL AS THEY WERE STORED FOR A PROLONGED PERIOD OF TIME, WHICH WAS OUTSIDE OF THE CLAIMS IN THE PACKAGE INSERT. (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 THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE RELATED (B)(6). PMA P100020. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) ALLEGED THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS 4800 (B)(6) TEST, (B)(6). SPECIFICALLY, THE CUSTOMER WAS PERFORMING A VALIDATION STUDY AND RAN SAMPLES THAT WERE PREVIOUSLY TESTED IN 2009. THE CUSTOMER CLAIMS THAT THE RE-TESTED SAMPLES HAVE GENERATED DISCREPANT RESULTS WITH THE COBAS 4800 (B)(6) TEST, (B)(6). THE SAMPLES WERE NOT STORED ACCORDING TO THE PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 4800 HPV TEST, CE-IVD KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS MAQ ROCHE MOLECULAR SYSTEMS 65501801

    Patients

    Seq Age Sex Outcome Treatment
    1