MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANC TEST KIT

Catalog Number 21347

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 from the united states reported to biomérieux a misidentification of fusobacterium as clostridium in association with the vitek® 2 anc test kit.The customer reported that the test was repeated and the same result was obtained.The customer stated the mass spectrometry result matched the expected organism identification.No additional information has been provided from the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states had reported to biomérieux a misidentification of fusobacterium as clostridium in association with the vitek® 2 anc test kit.An internal biomérieux investigation was performed.The customer strain was not submitted for evaluation.No information was provided concerning the customer's set up procedure.Without strain, raw data or lab report, no further evaluation of the mis-identification can be performed.Vitek® 2 anc test kit, lot # 2440293203 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC TEST KIT
• 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: 7083036
• MDR Text Key: 94990554
• Report Number: 1950204-2017-00429
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: 09/15/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440293203
• Other Device ID Number: 03573026144364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1