MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE TEST KIT; 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 in (b)(6) contacted biomérieux to report misidentification of staphylococcus aureus as staphylococcus lugdunensis in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Articular bone samples were processed via vitek® 2 gp id card.The result observed was staphylococcus lugdunensis.Since the laboratory technician suspected staphylococcus aureus from agglutination test, she repeated the test via different lot of gp id card; the same result was obtained.Testing at a different laboratory via alternate method (mass spectometry) provided a result of staphylococcus aureus.The customer indicates a delay of 48 hours in reporting results.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) had contacted biomérieux to report the misidentification of staphylococcus aureus as staphylococcus lugdunensis in association with the vitek® 2 gram-positive (gp) identification (id) test kit.An internal biomérieux investigation was performed; however, a viable strain was not received for the investigation.The customer reported setting up the strain (from several samples from the same patient) on cba incubated for 24 hours at 37c in ambient air.It was noted that purity, optics and densichek were indicated as being ok.There were no issues with samples from other patients.Twelve (12) lab reports were submitted.The following lab reports all showed very good identifications of s.Lugdenensis with two (2) atypical negative reactions (aglu, phos) for an identification of s.Aureus according to the vitek gp knowledge base: three (3) from (b)(6) 2017.Two (2) from (b)(6) 2017.One (1) from (b)(6) 2017.One (1) from (b)(6) 2017.One (1) lab report from (b)(6) 2017 showed a good identification of s.Aureus, and two (2) lab reports showed a low discrimination identification between s.Aureus and s.Lugdunensis, which is considered to be a correct call.One (1) lab report from (b)(6) 2017 showed a very good identification of staphylococcus pseudintermedius with three (3) atypical reactions (phos-, ure+, dman-) for an identification of s.Aureus according to the vitek gp knowledge base.Atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media, other user set up errors, or an atypical strain.However, without the strain or raw data, it was not possible to further evaluate the cause of the misidentification.The vitek 2 gp id test kit lot 2420460203 met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK® 2 GRAM POSITIVE TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 7119046
• MDR Text Key: 95900861
• Report Number: 1950204-2017-00453
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL. I 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420460203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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