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  

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the biomérieux internal cap d-10 strain was rehydrated and subcultured under anaerobic conditions.Testing included individual organism suspensions on anc cards from four different lots, in duplicate, and the vitek® ms.Exper/essay 5491/108 the eight (8) anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result.Testing with the vitek® ms resulted in the expected identification of p.Granulosum with a 99.5%confidence value.Review of the customers p.Anaerobius results against expected reactions for p.Granulosum demonstrated six atypical negative reactions (ellm, pyra, arg, pvate, amani, drib) and atypical positive morphology (gpc) according to the anc knowledge base and contributing to the misidentification.The customer reports a result of unidentified when entering morphology as gpr but this lab report was not saved for submittal.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Quality system review of the most recent quarterly trend report, 2017 q2, did not identify this complaint as a systemic quality issue.This is an atypical strain.

Event Description

A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 anc test kit (reference 21347).The customer reported that they missed cap d-b sample d10.Customer reported peptostreptococcus anaerobius based on a coccobacilli nomenclature, but should have been propionibacterium acnes (old nomenclature) or cutibacterium acnes (new nomenclature) using a bacilli morphology.The customer repeated on their second swab with bacilli morphology and got low discrimination with several clostridium species.Bacilli morphology did not show until day seven (7) of incubation.Customer tested at 48 hours after subculturing two times.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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; st. louis, MO 63042
• MDR Report Key: 7185432
• MDR Text Key: 97741607
• Report Number: 1950204-2018-00022
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• 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
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440202103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1