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

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 from the united states reported to biomérieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek® 2 gn test kit.The customer reported the isolate was tested four (4) times with vitek® 2 gn and received an identification of shigella sonnei.The isolate was sent to a state laboratory for serology testing (maldi-tof) and the isolate was determined to be escherichia coli.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The test reports were requested from the customer.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux a misidentification of an escherichia coli urine sample as shigella sonnei in association with the vitek® 2 gn test kit.An internal biomérieux investigation was performed.Testing included both a customer lot and a random lot of vitek® 2 gn cards.Api® 20 e was also performed.All cards tested gave an excellent id (99%) of s.Sonnei.Api® 20 e, however, gave a good identification (92.3%) of e.Coli.A comparison of expected reaction results for e.Coli resulted in three (3) atypical negative reactions (dsor, phos, ldc), which led to the misidentification.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.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.Root cause: atypical strain.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST CARD
• 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 ; 3147317301
• MDR Report Key: 6385695
• MDR Text Key: 69330703
• Report Number: 1950204-2017-00081
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1, EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241387640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1