BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL T3

    MDR report key: 4101509 · Received September 19, 2014

    Report

    Report Number
    3005094123-2014-00029
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 10, 2014
    Report Date
    September 4, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 38901UI01, EXPIRATION DATE 01/29/2015, LIST NUMBER 07K64-25. COMPLETE CORRECTION AND OR REMOVAL REPORTING NUMBER IS 3005094123-09/16/14-001-R. (B)(4). (B)(4). 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: 1-THE CUSTOMER CALIBRATES WITH A NOMINAL SOLIDS BOTTLE AND GENERATES RESULTS FROM THE CURVE USING A NOMINAL SOLIDS BOTTLE. NO IMPACT WILL OCCUR. 2-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. 3-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. 4-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 SCENARIO1. THE CORRECTION ACTIONS INCLUDED: 1-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. 2-QUALITY HOLD FOR THE AFFECTED REAGENT LOTS WAS ISSUED. 3-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

    ON (B)(6) 2014 IN ABBOTT DIAGNOSTICS DIVISION (B)(6), A COMPLAINT WAS RECEIVED IN RELATION TO CONTROLS OUT OF RANGE WHEN USING ARCHITECT TOTAL T3 7K64-20, LOT 38901UI00. THE CUSTOMER REPORTED THAT THE TOTAL T3 CALIBRATION IN THE CALIBRATION LOG DISPLAYED MUCH LOWER RELATIVE LIGHT UNITS RLUS COMPARED WITH OTHER KITS. QUALITY CONTROL DATA WAS OUT OF RANGE HIGH COMPARED TO LAB OR PEER GROUP RANGE. THE ARCHITECT TOTAL T3 (TT3) ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF TOTAL TRI-IODOTHYRONINE (TOTAL T3) IN HUMAN SERUM AND PLASMA. A PRODUCT DEFICIENCY WAS IDENTIFIED AND IN THE EVENT THAT CONTROLS DO NOT IDENTIFY THE ISSUE, PATIENT RESULTS MAY SHOW A POSITIVE BIAS OF UP TO 38%. FALSELY ELEVATED TOTAL T3 (TT3) RESULTS MAY BE REPORTED. A PATIENT WHO SHOULD BE FOLLOWED UP FOR POSSIBLE HYPOTHYROIDISM COULD BE CONSIDERED EUTHYROID AND A PATIENT WHO IS EUTHYROID COULD BE CONSIDERED HYPERTHYROID. NO IMPACT TO PATIENT HEALTH OR PATIENT MANAGEMENT HAS BEEN REPORTED. PHYSICIANS ARE UNLIKELY TO ACT ON THE BASIS OF A SINGLE TT3 RESULT. A PRODUCT RECALL WAS ISSUED UNDER 21CFR806 AND REPORTED TO FDA (B)(4) DISTRICT ON SEPTEMBER 11TH, 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584872 ARCHITECT TOTAL T3 TOTAL T3 CDP A.I.D.D LONGFORD 38901UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT INSTRUMENTS