MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a discrepant organism identification in association with the vitek 2 gram-positive (gp) identification (id) test kit.The gp id test kit reported the organism as streptococcus thoraltensis when it should have been streptococcus pneumoniae.There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to the patient's state of health.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported a misidentification of streptococcus pneumoniae as streptococcus thoraltensis in association with the vitek® 2 gram-positive (gp) identification test kit (card).As a troubleshooting measure the vitek® 2 instrument optics were replaced.Biomérieux investigation was conducted.The subsidiary in (b)(6) did not comply with requests to submit the replaced optics for internal investigation.Evaluation of the submitted vitek® 2 instrument logs (before optics replacement) indicated the original tx1 optic was frequently recalibrating to achieve the expected 3400rtu value prior to reading the test cards; however there were no instrument errors reporting that the calibration failed.This is normal instrument behavior.There was no data provided to indicate post-replacement behavior.Without submission of replaced product or patient strains, additional investigation is not possible.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5358701
• MDR Text Key: 35623239
• Report Number: 1950204-2016-00003
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242376440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• 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: Initial
• Patient Sequence Number: 1