BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL T3

    MDR report key: 4112278 · Received September 23, 2014

    Report

    Report Number
    3005094123-2014-00058
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CDP
    PMA / PMN Number
    K983439
    Removal / Correction Number
    3005094123-09/16/14-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER ANALYSIS OF THE DATA INDICATES THE REDUCED RLU VALUES ARE EVIDENT FOR MICROPARTICLE BOTTLES SEQUENTIALLY NUMBERED FROM 13835 ONWARDS. THESE BOTTLES ARE DERIVED FROM THE LATTER 17% OF THE MICROPARTICLE FILL (TOTAL LOT SIZE: 16,054 BOTTLES). THE INVESTIGATION HAS DETERMINED THAT 17% OF THE TWO IMPACTED REAGENT LOTS (38901UI00 AND 38901UI01) MAY EXHIBIT LOWER RELATIVE LIGHT UNITS (RLUS) THAN EXPECTED, WHICH IN TURN MAY RESULT IN CONTROLS OUT OF RANGE OR PATIENT RESULTS HIGHER THAN EXPECTED. INTERNAL TESTING OF FILE SAMPLES CONFIRMED THE CUSTOMERS OBSERVATION AND IT WAS DETERMINED THAT THE REDUCTION IN RLUS WAS RELATED TO THE EXISTENCE OF REDUCED PERCENT SOLIDS FROM THIS PORTION OF THE FILL. FOUR POSSIBLE UTILISATION SCENARIOS WITH THE IMPACTED REAGENT MAY BE OBSERVED: THE CUSTOMER CALIBRATES WITH A NOMINAL SOLIDS BOTTLE AND GENERATES RESULTS FROM THE CURVE USING A NOMINAL SOLIDS BOTTLE. NO IMPACT WILL OCCUR. THE CUSTOMER CALIBRATES WITH A NOMINAL SOLIDS BOTTLE AND LATER GENERATES RESULTS FROM THAT CURVE USING A LOW SOLIDS BOTTLE. THIS WILL RESULT IN A POSITIVE BIAS WHEN COMPARED TO SCENARIO 1.THE CUSTOMER CALIBRATES WITH A LOW SOLIDS BOTTLE AND LATER GENERATES RESULTS FROM THAT CURVE USING A NOMINAL SOLIDS BOTTLE. THIS WILL RESULT IN A NEGATIVE BIAS WHEN COMPARED TO SCENARIO 1. THE CUSTOMER CALIBRATES WITH A LOW SOLIDS BOTTLE AND GENERATES RESULTS FROM THAT CURVE USING A LOW SOLIDS BOTTLE. THIS WILL RESULT IN A POSITIVE BIAS WHEN COMPARED TO SCENARIO 1. THE CORRECTION ACTIONS INCLUDED: INTERNAL INTERIM ACTION: ADDITIONAL VERIFICATIONS HAVE BEEN INTRODUCED DURING FILLING PROCESS TO RECORD INFORMATION SUCH AS ACTUAL BOTTLE NUMBERS TESTED AND MIX SPEEDS PRIOR TO TRANSFER. QUALITY HOLD FOR THE AFFECTED REAGENT LOTS WAS ISSUED. A FIELD SAFETY CORRECTIVE ACTION (FSCA) IS PROPOSED FOR ISSUE TO ALL CUSTOMERS TO INFORM THEM OF THE EVENT AND INSTRUCT THEM TO: DISCONTINUE USAGE OF ARCHITECT TT3 REAGENT, LN 7K64-20, LOT 38901UI00 AND LN 7K64-25, LOT 38901UI01. (ALTERNATE IS TO ONLY DESTROY IMPACTED BOTTLES BASED ON SERIAL NUMBERS). REVIEW PATIENT RESULTS GENERATED USING THE LOTS ABOVE TO ENSURE ALIGNMENT TO OVERALL CLINICAL STATUS. 4-A QUALITY DIRECTIVE (QD) WITH Q&A WILL BE PROVIDED TO CALL REGISTRATION TO SUPPORT THEM WITH ANY QUERIES IMPACTED CUSTOMERS MAY HAVE. REPLACEMENT INVENTORY ARE AVAILABLE (7K64-20 AND 7K64-25; LOT 41919UI00; EXP: 20-MAY-2015, 7K64-30; LOT 41918UI01; EXP: 20-MAY-2015).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED CONTROLS OUT OF RANGE (OOR) HIGH WHEN USING ARCHITECT TOTAL T3 7K64-20, LOT 38901UI00. THE CUSTOMER RE-CALIBRATED BUT THE QC WAS STILL OOR HIGH. THE CUSTOMER CHANGED LOTS OF REAGENT AND THE QC WAS RIGHT ON THE MEAN. NO PATIENT RESULTS WERE GENERATED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591684 ARCHITECT TOTAL T3 TOTAL T3 CDP A.I.D.D LONGFORD 38901UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL # (B)(4)| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,