MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID TEST KIT

Catalog Number 21342

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the united states reported identification issues in association with the vitek® 2 gp test kit (lot 2420689403).The customer reported that the gp card did not identify multiple organisms correctly and that repeat tests were either the same identification or low discrimination.For isolate (b)(4), both the initial and repeat test results were streptococcus pseudoporcinus.The customer stated that isolate (b)(4) is an alpha strep.The customer did not provide the expected identification of the isolate.The customer reported that no incorrect treatment or harm to the patient occurred; however, the results were delayed greater than 24 hours.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed for a customer in the united states who reported identification issues in association with the vitek® 2 gp test kit.Multiple requests for strain submittal from the customer have been unsuccessful.The customer reported setting up the strains from bbl blood agar.They check sterility of their saline every day and autoclave their dispensette.Purity plates are set up for each isolate.No other set up information was provided.It was noted that fse "replaced reader section a ledge, belt and springs.Cleaned optics and inside the roller plate." the customer reported that they had service come in because "side a optics were getting white card dust on them.Card plastic was being shaved off every time it tried to read a card on side a.We think this is the problem.Problems seem to have subsided." seven (7) lab reports were submitted.However, without a definitive organism identification, an assessment of atypical reactions cannot be peformed.209815-3 x 2: low discrimination s.Agalactiae / s.Anginosus / s.Gordonii 200932-8: unidentified 201290-1: low discrimination s.Mitis/ s.Oralis / g.Adiacens / k.Kristinae 201290-8: unidentified 201303-1: good id s.Pseudoporcinus 201303-2: good id s.Pseudoporcinus atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non recommended media or other user set up errors or an atypical strain.However, in this case it appears that reader ledge contributed to the identification issues since problems resolved upon replacement.The vitek 2 gp id card, lot # 2420689403, met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Type of Device: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7831274
• MDR Text Key: 119659939
• Report Number: 1950204-2018-00314
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420689403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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