MAUDE Adverse Event Report: BIOMERIEUX, INC. FILMARRAY®

Model Number FLM1-ASY-0001U

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from (b)(6) reported a false positive candida parapsilosis for a blood culture in association with the filmarray® instrument.The positive blood culture had an unusual gram stain (no yeast detected) so the bcid (blood culture identification) panel was used for identification purposes.A subsequent culture was negative for candida, but brevundimonas diminuta was isolated.There was no definite yeast on gram or growth on selective agar.The initial filmarray® result did not match the clinical presentation therefore, a second aliquot was run on the filmarray® bcid panel and the result was negative.The patient was not on treatment prior to the blood culture.Fluconazole was administered to the patient based on the initial filmarray® result and then stopped accordingly.The customer confirmed that there was no adverse impact to the patient from the fluconazole treatment.An internal investigation was conducted.The test run files were analyzed internally to find the root cause for the issue.Review of the quality control records for pouch lot 269016 confirmed the lot met all quality control metrics and criteria.In addition, the pouch lot and the filmarray® instrument were found to be working within design specifications.The investigation has concluded that the most likely cause(s) are: b.5.1) differences in sensitivity between filmarray® and standard culture with a low level organism concentration near the limit of detection.The c.Parapsislosis melt signals observed in the initial run indicates a low level organism concentration is present within the sample.Polymicrobial detections can often be difficult to isolate, especially if the secondary organism is a slow growing yeast.B.5.2) contamination during sample testing.While the pouch loading instructions and recommended cleaning steps are sufficient to eliminate contamination the vast majority of the time, it is possible that some microbes could be introduced during any part of the testing process.B.5.3) low level pouch anomaly.The history of the filmarray® bcid product indicates that c.Parapsilosis false positive results have occurred in qc at a very low rate.Low level organism or nucleic acid could have been introduced into the testing reagents during manufacturing.The quality control measures for testing reagents, such as filmarray® bcid, screen for organism and nucleic acid contamination from a high confidence statistical sampling of each lot of reagents and other kit components.A 100% of very low level or sporadic contamination events may not be detected by this process in every instance.The lot was found to be working within product specifications.

• Brand Name: FILMARRAY®
• Type of Device: FILMARRAY®
• Manufacturer (Section D): BIOMERIEUX, INC.; 100 randolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX INC.; 100 randolphe street; durham NC 27712
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6312609
• MDR Text Key: 66835950
• Report Number: 3002769706-2017-00019
• Device Sequence Number: 1
• Product Code: NSU
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K143178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLM1-ASY-0001U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention