MAUDE Adverse Event Report: ACCELERATE DIAGNOTICS ACCELERATE PHENO SYSTEM; POSITIVE BLOOD CULTURE IDENTIFICATION AND AST KIT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  No Answer Provided  

Event Description

In summary, we are reporting this event because we are concerned about the high error rates when comparing pheno results to those of sensititre and other standard methods in our clinical microbiology laboratory.We suspect we are acutely aware of these issues because our antimicrobial stewardship team is heavily involved in the day-to-day functions of the clinical microbiology laboratory.We believe our practice of routinely performing additional susceptibility testing is likely providing resolution at a level not typically present in a clinical microbiology setting.We wanted to voice our concern, as there may be laboratories that do not utilize these additional methods, and patients may be receiving incorrect therapy or spectrum as a result.We are most concerned about the pseudomonas aeruginosa errors and, while mostly minor and due to overcalling of resistance, this often leaves very few actual treatment options and results in the addition of unnecessary therapy.We also want to highlight that implementation of our hospital's-specific rules for delayed reporting of ampicillin/sulbactam, cefazolin and piperacillin/tazobactam when nonsusceptible, prevented an additional 162 instances of overcalling resistance.While these errors have not resulted in obvious patient harm within our system, there has been a significant impact on patient care overall that we considered sufficient for reporting to the fda.

• Brand Name: ACCELERATE PHENO SYSTEM
• Type of Device: POSITIVE BLOOD CULTURE IDENTIFICATION AND AST KIT
• Manufacturer (Section D): ACCELERATE DIAGNOTICS; 3950 s. country club road suite 470; tuscon AZ 85714
• MDR Report Key: 9699497
• MDR Text Key: 178969677
• Report Number: 9699497
• Device Sequence Number: 1
• Product Code: PRH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1