BIOFIRE FILMARRAY GASTROINTESTINAL PANEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for BIOFIRE FILMARRAY GASTROINTESTINAL PANEL manufactured by Biofire Diagnostics Llc.

Event Text Entries

[137555228] Recent lots of the biofire filmarray gastrointestinal panel have yielded false detection of campylobacter species in clinical stool specimens. Seven patients received false positive results from the biofire filmarray gastrointestinal panel for campylobacter species in stool between (b)(6) 2019. These results were not reproducible by the filmarray assay and were negative by confirmatory stool culture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084453
MDR Report Key8374968
Date Received2019-02-26
Date of Report2019-02-22
Date Added to Maude2019-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIOFIRE FILMARRAY GASTROINTESTINAL PANEL
Generic NameQUANTITATIVE AND QUANTITATIVE MULTIPLEX NUCLEIC ACID DETECTION SYSTEM
Product CodePCH
Date Received2019-02-26
Lot Number416619
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBIOFIRE DIAGNOSTICS LLC
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-26

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