BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS 4800 HPV TEST, CE-IVD

    MDR report key: 3127363 · Received May 23, 2013

    Report

    Report Number
    2243471-2013-00013
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE ASSOCIATED US PRODUCT IS M/N 05235880190 P100020. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER (07-09-2013). DEVICE EVALUATED BY MANUFACTURER: YES. NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATIONS. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE. A PATIENT DIAGNOSED WITH ADENOCARCINOMA IN COLPOSCOPY GENERATED NEGATIVE RESULTS DURING INITIAL TESTING WITH THE COBAS 4800 HPV TEST. REPEAT TESTING WAS PERFORMED AND NEGATIVE RESULTS WERE GENERATED FOR "OTHER HIGH RISK HPV." THE SAMPLE WAS A LIQUID CYTOLOGY SAMPLE COLLECTED IN A LOCAL-BRANDED CELL COLLECTION MEDIA: (B)(4), WHICH IS CONSIDERED OFF-LABEL. ALTHOUGH REQUESTED, THE SAMPLE WAS NOT AVAILABLE FOR TESTING SO THE ALLEGATION COULD NOT BE CONFIRMED. THE COBAS 4800 HPV TEST HAS BEEN VALIDATED FOR THE USE OF CERVICAL SPECIMENS COLLECTED IN COBAS PCR CELL COLLECTION MEDIA, PRESERVCYT, AND SUREPATH PRESERVATIVE FLUID. THE PERFORMANCE OF A SAMPLE COLLECTED IN THE OFF-LABEL (B)(4) CELL COLLECTION MEDIA HAS NOT BEEN EVALUATED BY ROCHE, AND IS CONSIDERED AN OFF-LABEL APPLICATION OF THE TEST. THE RETAIN KITS WERE TESTED AND MET SPECIFICATIONS; THEREFORE, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT A PATIENT THAT WAS DIAGNOSED AS HAVING CERVICAL ADENOCARCINOMA BY COLPOSCOPY AND BIOPSY TESTED (B)(6) THREE TIMES FOR ALL HIGH RISK (B)(6) TYPES WITH THE COBAS 4800 (B)(4), CE-IVD. THE SAMPLE TESTED WAS A LIQUID CYTOLOGY SAMPLE COLLECTED IN (B)(6), A LOCAL-BRANDED CELL COLLECTION MEDIA, WHICH IS OFF-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229695 COBAS 4800 HPV TEST, CE-IVD KIT, DNA DETECTION, HUMAN PAPILLOMA VIRUS MAQ ROCHE MOLECULAR SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1