MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 60 BLUE MOD COLORM 110V

Model Number	27225
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of obtaining a false susceptible ciprofloxacin result in association with the vitek® 2 60 blue mod colorm 110v - (ref.27225, serial# (b)(4)) when testing a patient escherichia coli urine isolate.The customer tested the e.Coli isolate on two (2) separate vitek® 2 instruments while performing a comparison study.One instrument obtained a susceptible ciprofloxacin result while the other obtained a resistant ciprofloxacin result.The customer tested the isolate using the ciprofloxacin disc diffusion test method, a resistant result was obtained.A biomerieux field service engineer (fse) visited the customer site and noted the following issues on the impacted vitek® 2 instrument: loose instrument reader head belt, worn pulley, and white dust (from the test kits) in the instrument.The fse then replaced the tx 14 assembly, instrument belt and ledge.The isolate was then tested and obtained the expected susceptible ciprofloxacin.There is no adverse patient impact, the false susceptible result occurred during a comparison study.
Additional Manufacturer Narrative
An internal investigation was performed following notification from a customer in canada that they obtained a false susceptible ciprofloxacin result in association with the vitek® 2 60 blue mod colorm 110v - (ref.27225, serial# (b)(6)) when testing a patient escherichia coli urine isolate.Investigation on 24feb2022, the fse observed a loose belt, a worn pulley and white dust.As a correction, the fse replaced the reader belt, the reader ledge, the reader head pulley and the transmittance optics.Thereafter, the fse received confirmation from the customer that their qc and the comparison study passed.The transmittance optics were returned, however the reader belt, reader ledge and reader pulley were not returned.The transmittance optics were reviewed and tested, however no issues with the optics were identified.Therefore, a root cause could not be confirmed.Conclusion the root cause of this issue cannot be confirmed.

• Brand Name: VITEK® 60 BLUE MOD COLORM 110V
• Common Device Name: VITEK® 60 BLUE MOD COLORM 110V
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13776114
• Report Number: 1950204-2022-00012
• Device Sequence Number: 17099854
• Product Code: LON
• UDI-Device Identifier: 03573026162351
• UDI-Public: 03573026162351
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N50510-084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 02/09/2023
• Device Model Number: 27225
• Device Catalogue Number: 27225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown