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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification for a hand abscess sample from a patient, in association with the vitek® 2 gp test kit.Four samples from the patient were tested with the vitek® 2 gp card.Three samples (2 hemocultures, 1 arm abscess) were identified as streptococcus dysaglactiae spp equisimilis.The fourth sample (hand abscess) was identified as streptococcus agalactiae.A gp test was repeated the next day for the hand abscess, and the result was a low discrimination streptococcus dysaglactiae spp equisimilis / streptococcus agalactiae.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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux a misidentification for a hand abscess sample from a patient in association with the vitek® 2 gp test kit.The customer reported testing four samples from the same patient and received three results of streptococcus dysgalactiae spp equisimilis and one result of streptococcus agalactiae.Repeat testing the following day resulted in a low discrimination result between s.Agalactiae and s.Dysgalactiae ssp equisimilis.An internal biomérieux investigation was performed.The customer strain was not available for further evaluation.Testing was performed from isolates grown on blood agar (from biomedia) for 24 hr in air.No other set up information was provided.Three lab reports were submitted.One lab report showed a single choice identification of s.Dysgalactiae ssp equisimilis with one atypical positive reaction (pul) for an identification of s.Agalactiae according to the gp knowledge base.A second lab report showed a low discrimination result between s.Agalactiae and s.Dysgalactiae ssp equisimilis which would be considered a correct result.A third lab report showed a result of streptococcus porcinus but was noted there was operator error by the application specialist at the distributor so no analysis was performed.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 misidentification.Gp lot # 2420337403 met final qc release criteria.This lot passed initial 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: 6855186
• MDR Text Key: 86846272
• Report Number: 1950204-2017-00299
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420337403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2017
• 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