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

Catalog Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a misidentification of a propionibacterium granulosm cap survey sample as peptostreptococcus with the vitek® 2 anc test kit.The customer reported that the test was repeated three to five times and the result was the same.The customer is not able to submit the lab reports or isolate for evaluation.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A united states customer reported a misidentification of 2017 cap d-10 isolate of propionibacterium granulosum as peptostreptococcus anaerobius and unidentified when testing with the vitek® 2 anc test kit.An internal biomérieux investigation was completed.There was no strain or raw data submitted by the customer for evaluation.This cap sample was a simulated joint tissue from an elderly patient following hip replacement surgery.The challenge sample also contained s.Epidermidis.The specimen was not graded due to lack of participant and referee consensus.Referees demonstrated 49.2 % and participants 56.2 % consensus for correct identification of all organisms.The biomérieux internal cap d-10 strain was rehydrated and sub-cultured under anaerobic conditions.Testing included individual organism suspensions on anc cards from four different lots, in duplicate and the vitek® ms.The eight anc cards tested resulted in low discrimination identifications of multiple clostridium species, not the expected result.The vitek® ms resulted in the expected identification of p.Granulosum with a 99.5% confidence value.Review of customer's results against expected reactions for p.Granulosum demonstrated several atypical negative reactions (ellm, pyra, arg, pvate, amani, drib).Many participants additionally entered atypical positive morphology (cocci) according to the anc knowledge base all contributing to the misidentification.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.This is an atypical strain.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: 6905609
• MDR Text Key: 88408585
• Report Number: 1950204-2017-00323
• 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: 11/10/2017

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 Catalogue Number: 21347
• 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: 09/06/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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