MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT; VITEK® 2 GN ID CARD

Catalog Number 21341

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report a misidentification of (b)(6) specimen stenotrophomonas maltophilia as pseudomonas aeruginosa (or a low-discrimination result including the expected identification) in association with the vitek 2 gram-negative (gn) identification (id) test kit.Repeat testing obtained the same results.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.There was no patient directly associated with the (b)(6) strain.Culture submittal was requested by biomerieux for internal investigation.Biomerieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported a discrepant organism identification for a neqas external qc strain in association with the vitek® 2 gram-negative (gn) identification test kit (card).The organism was reported as pseudomonas aeruginosa by the hospital laboratory.The expected identification result was stenotrophomonas maltophilia.Investigational testing included: - vitek® ms: confirmed organism identification to stenotrophomonas maltophilia.- vitek® 2 gn id (customer lot and random lot): obtained two (2) low-discrimination results, neither of which proposed stenotrophomonas.- api® 20ne: result of "unacceptable profile".- id32gn: low discrimination due to atypical biochemical profile.The investigation did not reproduce the misidentification result obtained by the customer (pseudomonas aeruginosa).Based on the varied results obtained via multiple testing methods, the investigation concluded the neqas sample to be an atypical strain.There is no evidence to suggest the vitek® 2 gn id card is performing outside of specifications.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN ID 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6036705
• MDR Text Key: 57730125
• Report Number: 1950204-2016-00151
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241382510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2016
• 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