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

Catalog Number	21346
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: VITEK® 2 NH ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 6804092
• Report Number: 1950204-2017-00270
• Device Sequence Number: 1852688
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450221203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1