MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GP TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 united states reported identification issues in association with the vitek® 2 gp test kit (lot to 2420749203).The customer reported that the gp card did not identify multiple organisms correctly, especially viridans streptococci.The customer stated repeat tests were either the same identification or low discrimination.For isolate 201303-1, both the initial and repeat test results were streptococcus pseudoporcinus.The customer stated that isolate 201303-1 is an alpha strep.The customer did not provide the expected identification of the isolate.No patient information was provided by the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional 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 # 2420749203, met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GP TEST KIT
• Common Device Name: VITEK® 2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7824232
• Report Number: 1950204-2018-00308
• Device Sequence Number: 1143705
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: 12/15/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420749203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1