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 in (b)(6) reported to biomérieux a misidentification of staphylococcus haemolyticus as staphylococcus aureus in association with the vitek® 2 gp test kit.The customer stated an environmental strain from a production operator was identified as staphylococcus aureus by vitek® 2 gp although the coagulase test was negative.The customer performed a molecular test (microseq®) confirming a coagulase negative staphylococcus haemolyticus.There is no indication or report from the customer to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The test reports and isolate were received from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation concluded the following: no information was provided concerning the set up procedure.Two (2) laboratory reports were submitted showing an identification of s.Aureus and four (4) laboratory reports were submitted showing an identification of s.Haemolyticus.The laboratory report labeled isolate group 1: lab report shows a good identification of s.Aureus.There were four (4) atypical positive reactions (novo, dmne, bgal, mbdg) for an identification of s.Haemolyticus according to the gp knowledge base.The laboratory report labeled isolate group 2: lab report shows a very good identification of s.Aureus.There were two (2) atypical positive reactions (dmne, mbdg) for an identification of s.Haemolyticus according to the gp knowledge base.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.02mar2017 ind gp lot 2420050103 met final qc release criteria.There were no issues observed on 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: 6316120
• MDR Text Key: 67116143
• Report Number: 1950204-2017-00048
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/03/2017

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: 01/15/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420050103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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