BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC

    MDR report key: 15078129 · Received July 20, 2022

    Report

    Report Number
    MW5111028
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    July 31, 2021
    Report Date
    July 18, 2022
    Manufacturer
    THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC.
    Product Code
    JWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN COLLABORATION WITH CDC AND THREE OTHER AR LAB NETWORK PUBLIC HEALTH LABORATORIES, WE EVALUATED THE THERMOFISHER SENSITITRE GN7F PANEL. WE FOLLOWED THE SENSITITRE 037-NFAST FDA-USA ONLY INSTRUCTIONS FOR USE -CID: 10253. BASED ON PREVIOUS ISSUES WITH A RUO SENSITITRE PANEL (GNX2F), WE EVALUATED WHETHER THE GN7F PANEL HAD SIMILAR PERFORMANCE ISSUES. THE FIVE LABS IN THIS STUDY FOLLOWED THE SAME PROTOCOL TO EVALUATE THE DIFFERENT TRANSFER INOCULUM VOLUMES (STANDARD [10UL FROM 0.5 MCFARLAND EQUIVALENT TO 11ML CAMHB] AND INCREASED [30UL FROM 0.5 MCFARLAND EQUIVALENT TO 11ML CAMHB]) (SEE PG 4 IN IFU). IN ADDITION, WE EVALUATED THE PERFORMANCE OF THE SPECIFIC INOCULUM INSTRUCTIONS FOR THE PROTEEAE TRIBE ORGANISMS (1UL FROM 0.5 MCFARLAND EQUIVALENT TO 11ML CAMHB). THESE VARIOUS INOCULUM LEVELS WERE TESTED FROM THE SAME 0.5 MCFARLAND EQUIVALENT TO BE ABLE TO COMPARE THE EFFECT OF THESE INOCULUM METHODS. METHODS WERE OTHERWISE ACCORDING TO THE IFU, WITH THE EXCEPTION OF TWO LABS WHO USED A TURBIDITY METER INSTEAD OF A SENSITITRE NEPHELOMETER. ALL LABS MANUALLY READ THE GN7F PANEL. IN ONE LAB, IN ADDITION TO THE MANUAL READ, READ THE PANELS WITH THE ARIS 2X. ALL LABS TESTED THE SAME 100 ORGANISMS FROM THE CDC & FDA AR ISOLATE BANK (40 ENTEROBACTERALES, 30 P. AERUGINOSA, AND 30 A. BAUMANNII). THE GREATEST EFFECT OF THE 1UL/10UL STANDARD INOCULUM METHODS WAS OBSERVED FOR ENTEROBACTERALES. ALL LABORATORIES SAW THAT USING THE 1UL WITH THE PROTEEAE TRIBE UNDERCALLED RESISTANCE, SPECIFICALLY IN THE BETA-LACTAM AGENTS. AMONGST ALL LABORATORIES, USING THE 1UL FOR PROTEEAE TRIBE AND 10UL FOR NON-PROTEEAE TRIBE, NO LAB COULD OBTAIN ESSENTIAL AGREEMENT >90% FOR DORIPENEM, ERTAPENEM, IMIPENEM, MEROPENEM, CEFEPIME, PIPERACILLIN-TAZOBACTAM. ALL LABS OBSERVED AT LEAST 1 VERY MAJOR ERROR (UP TO 5) FOR DORIPENEM, ERTAPENEM, MEROPENEM, AZTREONAM, CEFTOLOZANE-TAZOBACTAM, AND PIPERACILLIN-TAZOBACTAM. INCREASING THE TRANSFER INOCULUM OF ALL ORGANISMS TO 30UL OR 50UL (OFF-LABEL) IMPROVED EA AND VERY MAJOR ERROR RATES. CDC WAS ALSO A PARTICIPANT IN THIS STUDY. WE'VE HELD MULTIPLE MEETINGS WITH THERMO FISHER SCIENTIFIC REGARDING THESE PROBLEMS, AND WERE LEFT UNRESOLVED. DATA CAN BE PROVIDED UPON REQUEST. LAB SPECIFIC DETAILS COMMENTS: MULTIPLE LOTS OF PLATES AND REAGENTS WERE USED SENSITITRE GN7F PLATE LOT(S): B0227A, B0336, B9521A SENSITITRE DH2O LOT(S): 920622, 922395, 996709 SENSITITRE 11ML CAMHB LOT(S): 114427, 920622, 922395, 992110 0.5 MCFARLAND TURBIDITY EQUIVALENT METHOD: MICROSCAN TURBIDITY METER READ METHOD(S) (MANUAL AND/OR AUTOREAD- INCLUDE S/N FOR ARIS): MANUAL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108724 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F B9521A
    108725 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 920622
    108726 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 996709
    108727 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 114427
    108728 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 922395
    108729 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 920622
    86623 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F B0227A
    86624 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 992110
    86625 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F 922395
    86626 THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS JWY THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. GN7F B0336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown