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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification result in association with vitek® 2 gp id test kit (ref 21342), lot 2420386103.Vitek® 2 identified qc strain, atcc700327 enterococcus casseliflavus, as enterococcus gallinarum.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient associated with this quality control strain.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported a misidentification of enterococcus casseliflavus as enterococcus gallinarum with the vitek® 2 gp id test kit (ref 21342), lot 2420386103.The customer's strain was not submitted for evaluation.An investigation was performed.The internal biomérieux qc strain was subcultured to remel tsab media.Testing included individual organism suspensions with vitek gp cards from the customer's lot and from a random lot, in duplicate.All four (4) gp cards gave the expected positive bgar reactions.No qc deviations or misidentifications were observed.The vitek 2 gp cards performed as expected for this strain when the recommended tsab media is used.The vitek2 gp lot 2420386103 met final qc release criteria and passed initial 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: 7100845
• MDR Text Key: 95516470
• Report Number: 1950204-2017-00438
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: C1 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: 04/11/2018

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: 12/17/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420386103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2017
• 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