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

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 a misidentification of a staphylococcus hominis patient isolate as staphylococcus capitus, in association with the vitek® 2 gp test kit ( lot 2420509103).The customer stated that the identification was staphylococcus capitus with the gp card, and staphylococcus hominis when testing with vitek® ms.The customer stated the media used was cos, and the quality and purity controls conformed.There was a delay greater than 24 hours for reporting results.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

This report was initially submitted following notification by a customer in france of a misidentification of staphylococcus hominis as staphylococcus capitis in association with the vitek® 2 gp id test kit.The customer did not comply with biomérieux's request for raw data or strain submittal.Evaluation of one lab report submitted by the customer indicated an excellent identification of staphylococcus capitis with seven (7) atypical reactions (positives: dman, dmne; negatives: ure, sac, dmal, dtre, aglu) for an identification of staphylococcus hominis according to the vitek® 2 gp knowledge base.An increased number of atypical 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 observed by the customer.Vitek® 2 gp id lot # 2420509103 met final qc release criteria.This lot passed initial qc performance testing.No ncmrs were written against this lot.Ncmrs were reviewed for the last 13 months (05jan17-05feb18) no ncmrs were written against gp id for performance issues.The investigation concluded the vitek® 2 gp id test kit is performing as intended.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP 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 ; 3147317301
• MDR Report Key: 7242544
• MDR Text Key: 99329973
• Report Number: 1950204-2018-00063
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420509103
• 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: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2017
• 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