MAUDE Adverse Event Report: BIOMERIEUX, INC PREVI® ISOLA

Catalog Number 29500

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of discrepant results associated with previ isola (reference 29500) related to a problem seeding on culture media plates.Culture media was identified as pvx anc and can2.The customer indicated discrepant results were not communicated to a physician and there was no patient impact or mistreatment.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported multiple patient specimens being inoculated onto the same media plate in association with the previ® isola system.Biomérieux investigation was conducted.Instrument log files were evaluated for entries or failures that would indicate a malfunction corresponding to multiple sample inoculations of different patient samples onto a single plate.Log files were also analyzed for the proper settings for rotation angle, set down angle and direction.These settings were found to be correct.Photos of the inoculated plates were analyzed.The photographs of the plates showed: · imprint of the applicator around the entire circumference of the plate · too many inoculation lines · organism growth and streak pattern not conducive to a single inoculation this detail suggests the plates had already been inoculated, and then re-inoculated.After reviewing the photos with subject matter experts, a likely use scenario was suggested: the previ® isola encounters an error after dispensing, and instructs the user to remove the plate from process station.The user complies, removes a processed plate without a label, and returns it to the input cassette (human error), where it is re-processed some time later.Information provided by the customer on 10jun2016 indicated that the customer may have returned plates to the input cassette following an error recovery (there was an error documented in the previ® isola logs with two respiratory specimens prior to when the plates in question were inoculated).The investigation concluded that based on the position and clustering of some colonies shown in the photographs, well outside of the streaking pattern, it appears very likely that the plates were contaminated during the error correction workflow, and should have been discarded.Also, the appearance of the applicator streaking pattern suggests the plates were previously processed on a previ® isola, i.E.They were likely involved in an error condition during inoculation and were returned to the input cassette by the user instead of being discarded.The previ® isola instrument is functioning as intended.

• Brand Name: PREVI® ISOLA
• Type of Device: PREVI® ISOLA
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5679904
• MDR Text Key: 47196554
• Report Number: 1950204-2016-00057
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29500
• Device Lot Number: AS180-00336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1