MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GN TEST KIT; VITEK® 2 GN TEST CARD

Catalog Number 21341

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 associated with the vitek® 2 ast-n233 test kit (reference (b)(4) involving an eeq cclin ouest strain.The customer reported the vitek® 2 ast-n233 card results were klebsiella oxytoca; however, the expected result was acinetobacter baumanii.The strain was tested twice on the vitek® 2 with the same results.In addition, the customer indicated testing with api® 20e and the result was acinetobacter baumanii.The customer indicated the discrepancy did not involve a patient or healthcare provider as it was an eeq strain that was tested.Therefore, there was no adverse events, negative impact or delays related to this discrepancy.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported the occurrence of a misidentification of acinetobacter baumannii (external control strain) as klebsiella oxytoca in association with the vitek® 2 gn id test kit.Biomérieux investigation was conducted using the strain submitted by the customer.The customer strain was subcultured on cba plate.Two different colonies was observed.Organism identification was performed via the following test methods for each colony type: vitek® ms - excellent identification to acinetobacter baumannii complex 99.9% for both colonies.Vitek® 2 gn id (customer lot and random lot) - excellent identification to acinetobacter baumannii complex on both lots tested.The customer result was not reproduced with the customer strain.The investigation concluded the vitek® 2 gn id test kit performed as intended.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST 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: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6605326
• MDR Text Key: 76536110
• Report Number: 1950204-2017-00171
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: 21341
• Device Lot Number: 2410071103
• Other Device ID Number: 03573026131913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2017
• 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