BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE COBAS AMPLIPREP INSTRUMENT

    MDR report key: 1145567 · Received September 4, 2008

    Report

    Report Number
    2243471-2008-00009
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 12, 2009
    Manufacturer
    ROCHE DIAGNOSTICS LTD
    Product Code
    JJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 2009, (84%) COUNTRIES NOTIFIED OF THIS ISSUE HAVE RESPONDED AND PROVIDED THE REQUESTED INFORMATION. A TOTAL OF 905 COBAS AMPLIPREP INSTRUMENTS CONTAINING 3620 DAMPERS HAVE BEEN INSPECTED IN THE FIELD. FORTY-TWO, OR 4.6% OF THE COBAS AMPLIPREP INSTRUMENT'S INSPECTED HAD AT LEAST ONE INCORRECT DAMPER INSTALLED. A TOTAL OF 138, OR 3.8% OF DAMPERS WERE FOUND TO BE INCORRECT. THE LOCATION OF THE INSTALLED INCORRECT DAMPERS WAS FAIRLY EVENLY DISTRIBUTED ACROSS THE FOUR POSSIBLE POSITIONS ON THE BEAD SHAKER [ LEFT FRONT (36), RIGHT FRONT (30), LEFT REAR (37) AND RIGHT REAR (35) ]. THE COBAS AMPLIPREP INSTRUMENTS HAVING THE WRONG DAMPERS INSTALLED WERE FOUND IN OTHER COUNTRIES. DAMPER INSPECTIONS ON INTERNAL COBAS AMPLIPREP INSTRUMENTS YIELDED NO INCORRECT DAMPERS ON ANY OF THE 88 TOTAL INSTRUMENTS INSPECTED. BECAUSE THE COBAS AMPLICOR ANALYZER MAINTENANCE SCHEDULE IS DIFFERENT THAN THE COBAS AMPLIPREP INSTRUMENT, AN INVESTIGATION OF THE IN-HOUSE ANALYZERS WAS PERFORMED PRIOR TO IMPLEMENTING INSPECTIONS IN THE FIELD TO DETERMINE IF THE WRONG DAMPERS INSTALLATION ALSO OCCURRED IN REVERSE. COBAS AMPLICOR ANALYZERS IN THE FACILITIES STILL HAD THE ORIGINAL, CORRECT DAMPERS INSTALLED FROM MANUFACTURE. NO INCORRECT DAMPERS HAVE BEEN FOUND ON THE 30 OF 180 COBAS AMPLICOR ANALYZERS INSPECTED TO DATE AT THE FACILITY. A REDESIGNED COBAS AMPLIPREP DAMPER IS CURRENTLY UNDERGOING VERIFICATION STUDIES THAT ARE SCHEDULED TO BE COMPLETED AT THE END OF 2009. BARRING ANY UNEXPECTED RESULTS, THE NEW DESIGN OF COBAS AMPLIPREP DAMPERS CAN BE IMPLEMENTED IN THE FOLLOWING MONTH.

    Additional Manufacturer Narrative · 1

    AS OF 07 MAY 2009, 45 OF THE 53 (85%) COUNTRIES NOTIFIED OF THIS ISSUE HAVE RESPONDED AND PROVIDED THE REQUESTED INFORMATION. A TOTAL OF 913 COBAS AMPLIPREP INSTRUMENTS CONTAINING 3652 DAMPERS HAVE BEEN INSPECTED IN THE FIELD. FORTY-TWO, OR 4.6% OF THE COBAS AMPLIPREP INSTRUMENTS INSPECTED HAD AT LEAST ONE INCORRECT DAMPER INSTALLED. A TOTAL OF 138, OR 3.8% OF DAMPERS WERE FOUND TO BE INCORRECT. RESPONSES ARE STILL PENDING FROM OTHER COUNTRIES. INSPECTIONS OF THE DAMPERS ON COBAS AMPLICOR ANALYZER IN INTERNAL STOCK HAVE BEEN COMPLETED. NO INCORRECT DAMPERS WERE FOUND IN THE 107 COBAS AMPLICOR UNITS INSPECTED. THE REDESIGNED COBAS AMPLIPREP DAMPER WAS RELEASED ON 12 MAR 2009 AND IMPLEMENTED IN OPERATIONS BEGINNING IN 30 MAR 2009. THE NEW VIBRATION DAMPERS AND U-SUPPORT ARE USED SINCE BEAD SHAKER AND THE FIRST SERIES AMPLIPREP WITH THE NEW PARTS WHICH IS CURRENTLY IN QC. THE MAINTENANCE KITS HAVE BEEN UPDATED IN THE INVENTORY. THE RELEASE OF THE SERVICE BULLETIN TO COMMUNICATE THE NEW SPARE PART NUMBER TO THE FIELD IS TO BE DISTRIBUTED BY 15 MAY 2009.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE WRONG VIBRATION DAMPERS WERE INSTALLED ON THE COBAS AMPLIPREP INSTRUMENT BEAD SHAKER.

    Description of Event or Problem · 1

    THE ANNUAL PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE COBAS AMPLIPREP INSTRUMENT DURING 2008, DURING WHICH TIME THE VIBRATION DAMPERS ON THE BEAD SHAKER WERE REPLACED WITH DAMPERS (LOT 462874). FOLLOWING THE MAINTENANCE THE CUSTOMER EXPERIENCED INVALID SAMPLES WHEN RUNNING TESTS USING THE SAME COBAS AMPLIPREP INSTRUMENT. THE INSTRUMENT WAS THEN UPGRADED TO BE A PART OF THE COBAS S201 SYSTEM IN ORDER TO RUN THE COBAS TAQSCREEN WEST NILE VIRUS TEST. DURING THE UPGRADE VALIDATION, THE AFFILIATE NOTICED THE SHAKER ON THE COBAS AMPLIPREP INSTRUMENT WAS NOISY, SHAKING IN A NON-ELLIPTICAL MANNER AND THE BEAD DISTRIBUTION WAS UNEVEN IN BOTH SPUS AND K-TUBES. IT WAS DETERMINED THAT THE DAMPERS WERE NOT ABSORBING THE VIBRATION BECAUSE 3 OF 4 WERE THE LESS RIGID DAMPERS FROM THE COBAS AMPLICOR ANALYZER LINE. THE TWO VERSIONS OF DAMPERS, ON FOR EACH INSTRUMENT LINE, ARE THE SAME SIZE AND COLOR BUT COME IN TWO DIFFERENT GRADES OF STIFFNESS (SHORE) FROM THE VENDOR.

    Description of Event or Problem · 1

    THE ANNUAL PREVENTIVE MAINTENANCE WAS PERFORMED ON THE COBAS AMPLIPREP INSTRUMENT DURING 2008, DURING WHICH TIME THE VIBRATION DAMPERS ON THE BEAD SHAKER WERE REPLACED WITH DAMPERS (LOT 462874). FOLLOWING THE MAINTENANCE THE CUSTOMER EXPERIENCED INVALID SAMPLES WHEN RUNNING TESTS USING THE SAME COBAS AMPLIPREP INSTRUMENT. THE INSTRUMENT WAS THEN UPGRADED TO BE A PART OF THE COBAS S 201 SYSTEM IN ORDER TO RUN THE COBAS TAQSCREEN WEST NILE VIRUS TEST. DURING THE UPGRADE VALIDATION, THE AFFILIATE NOTICED THE SHAKER ON THE COBAS AMPLIPREP INSTRUMENT WAS NOISY, SHAKING IN A NON-ELLIPTICAL MANNER AND THE THE BEAD DISTRIBUTION WAS UNEVEN IN BOTH SPUS AND K-TUBES. IT WAS DETERMINED THAT THE DAMPERS WERE NOT ABSORBING THE VIBRATION BECAUSE 3 OF 4 WERE THE LESS RIGID DAMPERS FROM THE COBAS AMPLICOR ANALYZER LINE. THE TWO VERSIONS OF DAMPERS, ONE FOR EACH INSTRUMENT LINE, ARE THE SAME SIZE AND COLOR BUT COME IN TWO DIFFERENT GRADES OF STIFFNESS (SHORE) FROM THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE COBAS AMPLIPREP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR JJH ROCHE DIAGNOSTICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1