MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 GN TEST KIT

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification in association with the vitek® 2 gn test kit (ref 21341).The customer reported the vitek® 2 gn test kit identified the organism as shigella; however, the strain was sent to the cnr for identification and the result came back as other than shigella.The customer reports that the sample was tested a total of three (3) times by the vitek® 2 instrument.Although this was a patient sample (urine), based on the information provided, there was no adverse events, negative patient impact or delay in results; however, incorrect results were reported to the physician.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed.After incubation, a heterogeneous population (called colony a and colony b) was observed.The expected result was confirmed on vitek® ms: identification to the species e.Coli (99.9%) with both colonies.With id32e strip, an excellent identification to e.Coli (99.9%) with one (1) test against (adh=3%) for colony a and none for colony b was obtained.The organism was subcultured on cba media and tested on two (2) vitek® 2 gn cards (customer lot 241385440 and random lot 241391540).On vitek® 2, with colony a on both vitek® 2 gn cards (customer and random lot) tested in-house, an excellent identification to escherichia coli (99%) was obtained.With colony b, on the customer lot, a low discrimination between esherichia coli and shigella group was obtained.With the random lot, a good identification to shigella group with the same biochemical profile of the customer result was obtained.After comparison of biochemical profiles between this profile (rl) obtained in-house and the expected profiles of e.Coli inactive, biomerieux observed three (3) tests against e.Coli inactive: bgal (96), llatk (4%) ldc.(4%).It should be noted that, when an identification of shigella is made by vitek® 2 gn cards, an analysis message of "confirm by serological tests" is given.Biomérieux duplicated the customer misidentification only on the random lot and the colony b due to the atypical biochemical profile of the isolate.In conclusion, we have a mix population with one e.Coli (colony a) and one e.Coli inactive(colony b).Root cause: mixed culture - colony a- correct id.Colony b - atypical strain.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.

• Brand Name: VITEK 2 GN TEST KIT
• Type of Device: VITEK 2 GN TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6148861
• MDR Text Key: 61602705
• Report Number: 1950204-2016-00198
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL I EXEMPT
• 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,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241385440
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1