BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP INSTRUMENT

    MDR report key: 1542211 · Received November 20, 2009

    Report

    Report Number
    2243471-2009-00016
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 22, 2009
    Report Date
    June 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS ISSUE INDICATED THAT THIS WAS THE RESULT OF A CERAMIC CAPACITOR, ON THE PRINTED CIRCUIT BOARD REAGENT RACK INDICATOR, OVERHEATING. THE PRELIMINARY ROOT CAUSE FOR THIS ISSUE WAS ATTRIBUTED TO HAIRLINE CRACKS IN THE CAPACITOR. FURTHER INVESTIGATION INTO THIS ISSUE IS ON-GOING. THE CUSTOMER'S COBAS AMPLIPREP INSTRUMENT WAS REPAIRED BY REPLACING THE PRINTED CIRCUIT BOARD REAGENT RACK INDICATOR.

    Additional Manufacturer Narrative · 1

    CONCLUSION: EVALUATION OF THE PCB MANUFACTURING PROCESS DETERMINED THAT THESE CIRCUIT BOARDS ARE CREATED IN A LARGER SHEET AND THEN CUT INTO SEPARATE BOARDS. THE TORSION FORCE APPLIED WHEN CUTTING OF THE BOARD IS SUSPECTED TO POSSIBLY CAUSE HAIRLINE CRACKS IN THE CAPACITOR. INVESTIGATION INTO THIS ISSUE WAS COMPLETED. THE INITIAL REPORT INDICATED THAT FLAME, SPARKS AND SMOKE WERE PRODUCED. HOWEVER, WHILE THERE WAS A SPARK AND SMOKE PRODUCED, A FLAME WAS NOT EVIDENT; RATHER, SMOLDERING WAS EVIDENT. THE PCB RACK INDICATOR IS AN ENERGY LIMITED CIRCUIT (5 VOLTS) THAT IS COVERED BY A PLEXIGLAS COVER AND IS NOT CLASSIFIED AS FLAMMABLE. IN GENERAL, ALL PCBS ARE ACCORDING TO UL 94 STANDARD. ANY POSSIBLE ASSOCIATED RISK AND RESULTING HARM CAUSED BY THIS EVENT IS CONSIDERED LOW. THERE IS NO EFFECT ON PCB FUNCTIONALITY, AS THERE ARE REDUNDANT CAPACITORS ON THE BOARD.AS INDICATED ABOVE, THESE CIRCUIT BOARDS ARE CREATED IN A LARGER SHEET AND THEN CUT INTO SEPARATE BOARDS. THE TORSION FORCE APPLIED WHEN CUTTING OF THE BOARD IS SUSPECTED TO POSSIBLY CAUSE HAIRLINE CRACKS IN THE CAPACITOR. THERE IS A CORRECTIVE ACTION BEING TAKEN TO REDESIGN THE BOARD TO REDUCE THE POSSIBILITY OF THIS OCCURRING.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER NARRATIVE WAS UPDATED TO INCLUDE ADDITIONAL/NEW INFORMATION REGARDING THE CORRECTIVE ACTION THAT WAS INITIATED. EVALUATION OF THE PCB MANUFACTURING PROCESS WAS PERFORMED, AND IT WAS DETERMINED THAT BURNT PCB REAGENT RACK INDICATORS WERE CAUSED BY HAIRLINE CRACKS ON THE PCB. AS A RESULT OF THIS FINDING, A CORRECTIVE ACTION WAS IMPLEMENTED TO REDESIGN THE PCB REAGENT RACK INDICATOR. THE REDESIGN CHANGES THE ORIENTATION OF THE CONDENSERS ON THE PCB TO REDUCE THE RISK OF HAIRLINE CRACKS. THE REDESIGNED PCBS WERE INCORPORATED INTO COBAS AMPLIPREP INSTRUMENTS (B)(4) AND HIGHER; THE CUSTOMER'S COBAS AMPLIPREP INSTRUMENT WAS MANUFACTURED PRIOR TO THIS REDESIGN.

    Description of Event or Problem · 1

    IN 2009 (SIX DAYS AFTER INSTALLATION), THE CUSTOMER REPORTED THAT, UPON TURNING-ON THE COBAS AMPLIPREP INSTRUMENT, SMOKE/SPARKS/FLAME WAS OBSERVED ON THE PRINTED CIRCUIT BOARD REAGENT RACK INDICATOR WITHIN A COBAS AMPLIPREP INSTRUMENT WHICH ALSO PARTIALLY MELTED THE PLEXIGLASS COVER FOR THE PRINTED CIRCUIT BOARD REAGENT RACK INDICATOR. THE SMOKE/SPARK/FLAME WAS ISOLATED TO THE PRINTED CIRCUIT BOARD REAGENT RACK INDICATOR AND THERE WAS NO INJURY TO PERSONNEL OR ADDITIONAL DAMAGE TO THE COBAS AMPLIPREP INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    CLARIFICATION WAS PROVIDED INDICATING THAT THE PRINTED CIRCUIT BOARD (PCB) REAGENT RACK INDICATOR WAS SMOLDERING AND NO FLAME WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR, 862.2310 JJH ROCHE DIAGNOSTICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1