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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a discrepant organism identification on the vitek® 2 gram-positive (gp) identification (id) test kit while testing an ansm organism (aerococcus urinae).The customer reported granulicatella adiacens.There is no indication or report from the hospital to biomérieux that the discrepant result led to any adverse event related to a patient's state of health.The ansm proficiency sample was not directly associated with any patient.Culture submittal has been requested by biomérieux for internal investigation.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.Testing via 16s sequencing provided an identification result of aerococcus urinae.Testing via vitek® 2 gp id test kit also gave results of aerococcus urinae.The investigation confirmed the intended result from (b)(4).Identification to the species aerococcus urinae was obtained on vitek® 2 gp id test kit.The customer misidentification was not duplicated.The vitek® 2 gp id test kit is performing as expected.

• 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 ; FR
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5189404
• MDR Text Key: 29923625
• Report Number: 1950204-2015-00085
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2016
• Device Catalogue Number: 21342
• Device Lot Number: 242346440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• 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