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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of staphylococcus lugdunensis as staphylococcus haemolyticus for an external quality control cap survey sample in association with the vitek® 2 gp test kit.The customer reported a new vitek® 2 installation occurred and the cap sample was tested without validation at the time.The staphylococcus haemolyticus (99%) was reported to cap and the customer found out it was the incorrect identification.The test reports and isolate were requested form the customer.A biomerieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation concluded the following: the internal cap d-18 strain was re-hydrated and testing included gp cards from two random lots in duplicate as well as the api staph test kit.All four (4) gram positive (gp) cards tested as well as the api staph kit resulted in excellent identifications of staphylococcus lugdunensis.For this strain, the vitek® 2 cards are performing as expected.Review of the customer's s.Haemolyticus reactions against expected reaction for s.Lugdunensis demonstrated four atypical reactions (dmne -, dman+, nag+, adh2s+) according to the gp knowledge base, contributing to the misidentification.An increase in atypical reactions can indicate an issue with the set up procedure, an atypical strain, mixed culture , contamination or decreased viability.Without the strain from the customer, it's not possible to further evaluate the cause of the misidentification.Cards are performing as expected.

• 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: 6360331
• MDR Text Key: 68410366
• Report Number: 1950204-2017-00068
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

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 Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2017; 04/05/2017
• 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