ACCELERATE PHENO SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for ACCELERATE PHENO SYSTEM manufactured by Accelerate Diagnotics.

Event Text Entries

[178969677] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9699497
MDR Report Key9699497
Date Received2020-02-12
Date of Report2020-01-24
Date of Event2020-01-01
Report Date2020-01-24
Date Reported to FDA2020-01-24
Date Reported to Mfgr2020-02-12
Date Added to Maude2020-02-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCELERATE PHENO SYSTEM
Generic NamePOSITIVE BLOOD CULTURE IDENTIFICATION AND AST KIT
Product CodePRH
Date Received2020-02-12
Device AvailabilityY
Device Age1 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerACCELERATE DIAGNOTICS
Manufacturer Address3950 S. COUNTRY CLUB ROAD SUITE 470 TUSCON AZ 85714 US 85714


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-12

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