BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLICOR CT/NG TEST

    MDR report key: 873321 · Received September 28, 2006

    Report

    Report Number
    2243471-2006-00011
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Report Date
    September 13, 2006
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT THAT ACCOMPANIES THE AMPLICOR CT/NG TEST STATES IN THE INSTRUCTIONS FOR USE SECTION, PART D AMPLIFICATION, STEP 3 "DURING RUN SET-UP, SET THE REACTION VOLUME TO 100UL BY FIRST CHANGING THE RAMP SPEED FROM THE 9600 MODE TO THE MAX MODE. TO DO THIS, CURSOR DOWN TO RAMP SPEED AND SELECT MAX". APPLIED BIOSYSTEMS GENEAMP PCR SYSTEM 9700 THERMAL CYCLERS WITH THE ALUMINUM HEAT BLOCK WILL NOT ACCEPT THIS SETTING. ONLY THERMAL CYCLERS EQUIPPED WITH THE GOLD-PLATED HEAT BLOCK WILL ACCEPT THE RAMP SPEED SETTING OF MAX. THE PURPOSE OF PROVIDING THE PRODUCT BULLETIN WAS TO PROVIDE ADDITIONAL INFORMATION ON THIS SETTING REQUIREMENT. ADD'L LOT # G14950.

    Description of Event or Problem · 1

    IN JUNE 2006, ROCHE MOLECULAR SYSTEMS, INC. PROVIDED A PRODUCT BULLETIN CLARIFYING THE USE OF THE GOLD PLATED HEAT BLOCK AND THE ALUMINUM HEAT BLOCK ON THE APPLIED BIOSYSTEMS GENEAMP PCR SYSTEM 9700 THERMAL CYCLER. IN RESPONSE TO THE THE BULLETIN, THE CUSTOMER REPORTED THEY HAD BEEN USING THE ALUMINUM HEAT BLOCK WHEN PERFORMING THE AMPLICOR CT/NG TEST. THE ALUMINUM HEAT BLOCK WILL NOT ACCEPT A MAXIMUM RAMP SPEED WHICH IS REQUIRED TO PERFORM THE AMPLICOR CT/NG TEST. THE CURRENT AMPLICOR CT/NG TEST PACKAGE INSERT DESCRIBES THE SETTING OF THE TEMPERATURE RAMP SPEED TO MAXIMUM BUT DOES NOT IDENTIFY THE HEAT BLOCK TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLICOR CT/NG TEST IN VITRO DIAGNOSTIC NUCLEIC ACID TEST MKZ ROCHE MOLECULAR SYSTEMS, INC. NA H02039

    Patients

    Seq Age Sex Outcome Treatment
    1 *