BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT

    MDR report key: 9838624 · Received March 17, 2020

    Report

    Report Number
    3010671651-2020-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 13, 2020
    Manufacturer
    ACCELERATE DIAGNOSTICS, INC.
    Product Code
    PRH
    UDI-DI
    00862011000314
    PMA / PMN Number
    DEN160032
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO UVA'S REPORT, ACCELERATE DIAGNOSTICS REVIEWED THE DEVICE'S POST-MARKET SURVEILLANCE DATA FOR (1) P. AERUGINOSA AST, (2), AMPICILLIN-SULBACTAM (SAM) AND (3) PIPERACILLIN-TAZOBACTAM (TZP). USING PEARSON'S CHI-SQUARED TEST (P-VALUE >0.05), IT WAS DETERMINED THAT SAM AND TZP PERFORMANCE WERE NOT STATISTICALLY DIFFERENT FROM THE AST PERFORMANCE CLAIMED IN TABLE 12-7 OF THE DEVICE'S INSTRUCTIONS FOR USE (IFU). FOR P. AERUGINOSA AST, FOUR ANTIMICROBIALS EXCEEDED A <= 3% MAJOR ERROR RATE. THESE INCLUDED, CEFTAZIDIME, CEFEPIME, MEROPENEM AND PIPERACILLIN-TAZOBACTAM. THE PRODUCT IFU, TABLE 11-3, CONTAINS LIMITATIONS FOR AST WITH CEFEPIME AND CEFTAZIDIME, INDICATING A RISK FOR MAJOR ERRORS: "THE FOLLOWING ANTIMICROBIAL/ORGANISM COMBINATIONS MAY PRODUCE A RESISTANT RESULT THAT CAN BE FOUND SUSCEPTIBLE BY THE REFERENCE METHOD. IF CRITICAL TO PATIENT CARE, CONFIRM THESE RESULTS WITH AN ALTERNATE METHOD." THE CURRENT PRODUCT IFU DOES NOT INCLUDE LIMITATIONS FOR PIPERACILLIN-TAZOBACTAM OR MEROPENEM. WHILE OVERALL PERFORMANCE CLAIMS FOR THESE ANTIMICROBIALS WERE NOT STATISTICALLY DIFFERENT FROM THE AST PERFORMANCE CLAIMED IN THE ACCELERATE PHENOTEST® BC KIT IFU, ACCELERATE DIAGNOSTICS HAS CHOSEN TO ADD THE FOLLOWING LIMITATIONS TO THE IFU TO ENSURE PATIENT SAFETY: "THE FOLLOWING ANTIMICROBIAL/ORGANISM COMBINATIONS MAY PRODUCE A RESISTANT RESULT THAT CAN BE FOUND SUSCEPTIBLE BY THE REFERENCE METHOD. IF CRITICAL TO PATIENT CARE, CONFIRM THESE RESULTS WITH AN ALTERNATE METHOD: PIPERACILLIN/TAZOBACTAM / PSEUDOMONAS AERUGINOSA, MEROPENEM / PSEUDOMONAS AERUGINOSA." ADDITIONALLY, THE FOLLOWING FOOTNOTES WILL BE ADDED TO TABLE 12-7 IN THE IFU: "AN INCREASED RATE OF MINOR ERRORS WERE OBSERVED FOR ENTEROBACTER SPP AND CITROBACTER SPP WITH CEFTAZIDIME. AN INCREASED RATE OF MINOR ERRORS WERE OBSERVED FOR ENTEROBACTER SPP. AND PIPERACILLIN-TAZOBACTAM." ACCELERATE DIAGNOSTICS HAS MADE IMPROVEMENTS TO THE ACCELERATE PHENOTEST® BC KIT AST ASSAY FOR PAE WITH THE BETA-LACTAMS (CEFTAZIDIME, CEFEPIME, PIPERACILLIN/TAZOBACTAM, MEROPENEM, AND AZTREONAM), AND THE COMPANY HAS PROVIDED EVIDENCE OF SAFETY AND EFFICACY IN A 510(K) SUBMISSION CURRENTLY UNDER REVIEW BY THE FDA (K192665). THE AST ASSAY MODIFICATIONS ADDRESS THE MAJOR ERROR LIMITATIONS FOR PAE WITH CEFEPIME AND CEFTAZIDIME AND ALSO IMPROVE AST PERFORMANCE FOR PAE WITH PIPERACILLIN/TAZOBACTAM AND MEROPENEM.

    Description of Event or Problem · 1

    ACCELERATE DIAGNOSTICS HAS INVESTIGATED THE PERFORMANCE CHALLENGES REPORTED BY (B)(6) MEDICAL CENTER IN MEDWATCH FORM 3500A, REPORT (B)(4). THREE PERFORMANCE CONCERNS WERE REPORTED. FOR THE ORGANISM PSEUDOMONAS AERUGINOSA, UVA REPORTED AST MINOR ERRORS WITH ACCELERATE PHENOTEST® BC KIT RESULTING IN OVERCALLING OF RESISTANCE FOR THIS ORGANISM, AS COMPARED TO THEIR STANDARD OF CARE METHOD, SENSITITRE. THE ANTIMICROBIALS FOR WHICH THIS WAS OBSERVED WERE NOT SPECIFIED BY UVA. FOR THE ANTIMICROBIAL, AMPICILLIN-SULBACTAM, UVA REPORTED THE ACCELERATE PHENOTEST® BC KIT OVERCALLED RESISTANCE AS COMPARED TO SENSITITRE. FOR THE ANTIMICROBIAL, PIPERACILLIN-TAZOBACTAM, UVA REPORTED THE ACCELERATE PHENOTEST® BC KIT OVERCALLED RESISTANCE AS COMPARED TO THEIR STANDARD OF CARE, SENSITITRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303888 ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT ACCELERATE PHENO SYSTEM PRH ACCELERATE DIAGNOSTICS, INC. 10401008 00862011000314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other