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

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification of streptococcus dysgalactiae as streptococcus agalactiae for a throat (angine) sample, in association with the vitek® 2 gp test kit.The customer reported the vitek® 2 twice identified the sample as streptococcus agalactiae (99%), and the vitek ms® identified streptococcus dysgalactiae (= strepto c).The customer stated the incorrect identification was reported to the clinician and there was no impact to the patient or treatment.There was a delay greater than 24 hours for reporting results to the clinician.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported the occurrence of a misidentification of streptococcus dysgalactiae as streptococcus agalactiae in association with the vitek® 2 gp identification test kit (card).The customer submitted the patient isolate for investigational testing.Vitek® 2 gp id card lots 2420136103 and 2420157103 met final qc release criteria.There were no issues observed on initial qc performance testing.There were no ncmrs written against these lots.Ncmrs were reviewed for the last 13 months and there were none written for misidentifications on the gp product line.Investigational testing included: reference method (sequencing soda) - organism identification to streptococcus dysgalactiae ssp equisimilis api® 20 strep - organism identification to streptococcus dysgalactiae ssp equisimilis vitek® 2 gp id cards (two customer lots 24201136103 and 2420157103): 24201136103 - excellent identification to streptococcus dysgalactiae ssp equisimilis (99%).2420157103 - obtained different result on two different cards; excellent identification to streptococcus dysgalactiae ssp equisimilis (99%), and excellent identification to streptococcus agalactiae (99%).The investigation reproduced the discrepant customer result on 1/3 gp id cards.The organism strain is not reproducible.The investigation concluded the isolate submitted isolates has an atypical biochemical profile; there is no evidence to suggest the vitek® 2 gn id card is performing outside of specifications.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP 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: 6375853
• MDR Text Key: 69020801
• Report Number: 1950204-2017-00076
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952095
• 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,Followup
• Report Date: 07/12/2017

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: 04/11/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420136103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 06/15/2017; 06/15/2017
• Supplement Dates FDA Received: 07/12/2017; 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• 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