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Accelerate Pheno™ System 10401008Recalls & reported problems

Accelerate Diagnostics, Inc. · The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples. Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00862011000314), received between Oct 23, 2019 and Mar 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Therapeutic Response, Increased1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    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.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9838624 ↗
  • MalfunctionOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCELERATE PHENO¿ SYSTEM REPORTED PSEUDOMONAS AERUGINOSA (FALSE POSITIVE). THE PATIENT RECEIVED AN ESCALATION OF ANTIBIOTICS, AN ID CONSULT, AND CT CHEST/ABDOMEN/PELVIS TO IDENTIFY THE SOURCE OF THE INFECTION. THE COMPARATOR METHOD (MALDI-TOF) IDENTIFIED ESCHERICHIA COLI. A PATIENT ADMITTED WITH ASCENDING CHOLANGITIS HAD BLOOD CULTURES TAKEN FOR IDENTIFICATION (ID)AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST). THE ACCELERATE PHENO¿ SYSTEM ID RESULT INDICATED THAT THE PATIENT WAS INFECTED WITH DRUG-RESISTANT PSEUDOMONAS AERUGINOSA. IN RESPONSE, ANTIBIOTIC TREATMENT WAS ESCALATED USING CEFEPIME, AN ID CONSULT WAS INITIATED, AND THE PATIENT RECEIVED A CT CHEST/ABDOMEN/PELVIS TO IDENTIFY THE SOURCE OF THE PAE INFECTION AND DETERMINE WHETHER IT WAS PRESENT ON THE PATIENT'S SPINAL HARDWARE. AFTER 24 HOURS, COMPARATIVE TEST (MALD-TOF) RESULTS IDENTIFIED THE BACTERIA AS ESCHERICHIA COLI, NOT PSEUDOMONAS AERUGINOSA. PATIENT THERAPY WAS THEN DEESCALATED TO ORAL CIPROFLOXACIN. THE PATIENT RESPONDED WELL AND WAS DISCHARGED ON THE ORAL CIPROFLOXACIN.

    Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Response, Increased

    MAUDE report 9227519 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.