BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T3

    MDR report key: 8039763 · Received November 5, 2018

    Report

    Report Number
    3005094123-2018-00064
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Report Date
    November 5, 2018
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CDP
    UDI-DI
    00380740014285
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3005094123-10/22/18-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CORRECTION LETTERS WERE ISSUED ON 12OCT2018 TO ALL ARCHITECT TOTAL T3 (TT3) AND FREE T3 (FT3) CUSTOMERS, USING THE I1000SR, I2000, OR I2000SR INSTRUMENTS AND WHO RECEIVED ONE OF THE LOTS LISTED BELOW. THE LETTER INSTRUCTED THE CUSTOMERS TO PREVENT THIS INTERACTION BY EITHER SEPARATING THE ARCHITECT FT3 AND/OR ARCHITECT TT3 ASSAYS BY RUNNING THESE TESTS ON DIFFERENT INSTRUMENTS FROM THE FOLLOWING ASSAYS [ARCHITECT TSH, ARCHITECT T-UPTAKE, ARCHITECT HIV AG/AB COMBO, ARCHITECT CORTISOL, ARCHITECT LH, ARCHITECT PROGRP, ARCHITECT RHTLV-I/II, ARCHITECT TOTAL PSA, ARCHITECT AFP, AND ARCHITECT FREE PSA, ARCHITECT 25-OH "VIATMIN" D], OR BY PERFORMING DAILY MAINTENANCE ON THE INSTRUMENT PRIOR TO PERFORMING BATCH TESTING FOR ALL FT3 AND/OR TT3 SAMPLES. THE MECHANISM OF CARRYOVER INVOLVES CARRYOVER OF POLY-L-LYSINE (PLL) FROM OTHER ASSAYS INTO THE CONJUGATE DISPENSE STEP IN THE FT3 AND TT3 ASSAYS THROUGH ADHERENCE OF THE PIPETTING PROBE. COMPLETE "INFORMATON" FOR 3005094123-10/22/18-001-C: THIS CORRECTION INCLUDES THE FOLLOWING PRODUCTS FOR SUSPECT MEDICAL DEVICE: ARCHITECT FREE T3: CATALOG 07K63-25: UDI (B)(4), LOTS: 83223UI01, DOM 19DEC17 / EXP 29OCT18; 84208UI00, DOM 31JAN18 / EXP 09DEC18; 84208UI01, DOM 06FEB18/ EXP 09DEC18; 86072UI00, DOM 30MAR18 / EXP 06FEB19; 87009UI00, DOM 02MAY18 / EXP 28FEB19; 89120UI00, DOM 30JUN18 / EXP 25APR19; 90073UI00, DOM 25JUL18 / EXP 27MAY19; 90073UI01, DOM 27JUL18 / EXP 27MAY19; 92007UI00, DOM 25SEP18 / EXP 12AUG19. CATALOG 07K63-27: UDI (B)(4), LOTS: 82340UI00, DOM19DEC17 / EXP 27OCT18; 84081UI00, DOM 05FEB18 / EXP 20NOV18; 85412UI00, DOM 31MAR18 / EXP 21JAN19; 87373UI00, DOM 21MAY18 /EXP 03MAR19; 88217UI00, DOM 22JUL18 / EXP 18MAY19; 90345UI00, DOM 03SEP18 / EXP 01JUL19. CATALOG 07K63-30: UDI (B)(4), LOTS: 83219UI00, DOM 12DEC17 / EXP 29OCT18; 84204UI00, DOM 10FEB18 / EXP 09DEC18; 86068UI00, DOM 28MAR18 / EXP 06FEB19; 87006UI00, DOM 30APR18 / EXP 28FEB19; 89117UI01, DOM 29JUN18 / EXP 25APR19; 90070UI01, DOM 31JUL18 / EXP 27MAY19; 92003UI01, DOM 24SEP18 / EXP 12AUG19. CATALOG 07K63-32: UDI (B)(4), LOTS: 82337UI01, DOM 15DEC17 / EXP 27OCT18; 84078UI00, DOM 02FEB18 / EXP 20NOV18; 85409UI01, DOM 28MAR18 / EXP 21JAN19; 87370UI01, DOM 15MAY18 / EXP 03MAR19; 90341UI00, DOM 14AUG18 / EXP 01JUL19. CATALOG 07K63-35: UDI (B)(4), LOTS: 83219UI01, DOM 14DEC17 / EXP 29OCT18; 84204UI01, DOM 09FEB18 / EXP 09DEC18; 86068UI01, DOM 28MAR18 / EXP 06FEB19; 87006UI01, DOM 29APR18 / EXP 28FEB19; 89117UI00, DOM 28JUN18 / EXP 25APR19; 90070UI00, DOM 31JUL18 / EXP 27MAY19; 92003UI00, DOM 23SEP18 / EXP 12AUG19. CATALOG 07K63-37: UDI (B)(4), LOTS: 82337UI00, DOM 15DEC17 / EXP 27OCT18; 84078UI01, DOM 03FEB18 / EXP 20NOV18; 85409UI00, DOM26MAR18 / EXP 21JAN19; 87370UI00, DOM 16MAY18 / EXP 03MAR19; 90247UI00, DOM 03JUL18 / EXP 18MAY19; 90341UI01, DOM 15AUG18 / EXP 01JUL19. ARCHITECT TOTAL T3; TOTAL TRIIODOTHYRONINE: CATALOG 07K64-25: UDI (B)(4), LOTS: 80152UI00, DOM 31OCT17 / EXP 23OCT18; 83058UI00, DOM 12DEC17 / EXP 07DEC18; 84168UI00, DOM 19FEB18 / EXP 19JAN19; 88128UI00, DOM 13JUN18 / EXP 23APR19; 90326UI00, DOM 30JUL18 / EXP 19JUL19; 91232UI00, DOM 21AUG18 / EXP 03AUG19; 91232UI01, DOM 31AUG18 / EXP 03AUG19. CATALOG 07K64-27: UDI (B)(4), LOTS: 83198UI00, DOM 13JAN18 / EXP 06NOV18; 85169UI00, DOM 15MAR18 / EXP 20JAN19; 90357UI00, DOM 09JUL18 / EXP 24APR19; 92062UI00, DOM 19AUG18 / EXP 10JUL19; 92062UI01, DOM 20AUG18 / EXP 10JUL19. CATALOG 07K64-30: UDI (B)(4), LOTS: 80149UI01, DOM 29OCT17 / EXP 23OCT18; 82347UI00, DOM 11DEC17 / EXP 07DEC18; 84165UI00, DOM 27FEB18 / EXP 19JAN19; 88124UI00, DOM 13JUN18 / EXP 08MAY19; 90322UI00, DOM 09AUG18 / EXP 19JUL19; 91229UI00, DOM 11SEP18 / EXP 03AUG19. CATALOG 07K64-32: UDI (B)(4), LOTS: 83073UI00, DOM 09JAN18 / EXP 06NOV18; 85165UI00, DOM 14MAR18 / EXP 20JAN19; 86193UI01, DOM 24AUG18 / EXP 10JUL19; 89318UI00, DOM 29MAY18 / EXP 18APR19. CATALOG 07K64-35: UDI (B)(4), LOTS: 80149UI00, DOM 29OCT17 / EXP 23OCT18; 82347UI01, DOM 12DEC17 / EXP 07DEC18; 84165UI01, DOM 27FEB18 / EXP 19JAN19; 88124UI01, DOM 13JUN18 / EXP 08MAY19; 90322UI01, DOM 09AUG18 / EXP 19JUL19. CATALOG 07K64-37: UDI (B)(4), LOTS: 83073UI01, DOM 09JAN18 / EXP 06NOV18; 85165UI01, DOM 14MAR18 / EXP 20JAN19; 86193UI00, DOM 23AUG18 / EXP 10JUL19.

    Description of Event or Problem · 1

    IN RESPONSE TO A CUSTOMER COMPLAINT, ABBOTT HAS CONFIRMED A CARRYOVER EVENT OCCURRING WITH ARCHITECT FREE T3 (FT3) AND/OR ARCHITECT TOTAL T3 (TT3). THE CARRYOVER IS DRIVEN BY POLY-L-LYSINE (PLL) WHICH IS A COMPONENT OF A SUB-SET OF ABBOTT REAGENTS AND MAY CAUSE FALSELY DECREASED RESULTS. ADDITIONAL INVESTIGATION BASED ON THE MECHANISM OF CARRYOVER, CONFIRMED THE POTENTIAL FOR 10 DIFFERENT REAGENTS TO CARRYOVER TO ARCHITECT FT3 AND/OR TT3 ON THE ARCHITECT I1000SR PLATFORM. THE INVESTIGATION ALSO "IDENTIIFED" THAT THE 25-OH VITAMIN D ASSAY MAY CARRY OVER TO FT3 AND/OR TT3 ON THE ARCHITECT I2000/I2000SR PLATFORM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876591 ARCHITECT FREE T3 FREE TRIIODOTHYRONINE CDP A.I.D.D LONGFORD 83223UI00 00380740014285

    Patients

    Seq Age Sex Outcome Treatment
    1