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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states reported a misidentification of a streptococcus agalactiae api survey sample, as streptococcus thoraltensis in association with the vitek® 2 gp test kit.The customer reported that the identification from the first survey swab was reported as streptococcus thoraltensis.After learning the expected result was streptococcus agalactiae, the customer tested the second swab and the result was streptococcus agalactiae low discrimination.Both test runs were positive for d-amygdalin, pullulan, and d-raffinose when they should have been negative for the expected result.There was no patient involvement as this event was for a survey sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states had reported to biomérieux a misidentification of a streptococcus agalactiae api survey sample as streptococcus thoraltensis in association with the vitek® 2 gp id test kit.An internal biomérieux investigation was performed.The strain was not available to submit for investigation.The customer reported setting up the isolate from bbl tsa with 5% sheep blood and incubating the strain in 5% co2 at 36c for 18-24hrs.Two lab reports were submitted.The first showed a good identification of s.Thoraltensis with 4 atypical positive reactions (amy, draf, dxyl, pul) for an identification of s.Agalactiae according to the gp knowledge base.The second lab report showed a low discrimination identification between s.Agalactiae and s.Dysgalactiae ssp equisimilis.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain.However, without the strain or raw data it's not possible to further evaluate the cause of the mis-identification.Gp lot# 2420029103 met final qc release criteria.This lot passed qc performance testing.

• 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: 6945580
• MDR Text Key: 90310288
• Report Number: 1950204-2017-00335
• Device Sequence Number: 1
• Product Code: LQL
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2017
• Device Catalogue Number: 21342
• Device Lot Number: 2420029103
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1