MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 NH ID TEST KIT

Catalog Number 21346

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 in the (b)(6) notified biomérieux of misidentification for campylobacter jejuni as neisseria cinerea or unidentified organism in association with vitek® 2 nh id test kit, lot 2450221203.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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: no information was provided concerning the customer's set up procedure.Fourteen (14) laboratory reports were attached to the complaint record of which seven (7) were duplicates.Five (5) lab reports (72476, 73387, 74087, 74582, and 75744) showed a result of very good n.Cinerea with six (6) atypical negative reactions (pyra, odc, lglm, pvate, ops, dmlt) for an identification of c.Jejuni according to the nh knowledge base.Two (2) laboratory reports (72431 campy, 72431 c jejuni) showed a result of unidentified organism.The first laboratory report showed seven (7) atypical reactions (atypical negative: odc, lglm, dmlt and atypical positive: mte, dmne, nag, dglu) and the second laboratory report showed eight (8) atypical reactions (atypical negative: odc, lglm, pvate, ops, dmlt; atypical positive: mte, dmne, nag) for an identification of c.Jejuni according to the nh knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.Nh lot #2450221203 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 NH ID TEST KIT
• Type of Device: VITEK® 2 NH ID 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: 6804092
• MDR Text Key: 83943265
• Report Number: 1950204-2017-00270
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/21/2017

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 Expiration Date: 07/05/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450221203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• 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