MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GP75 TEST KIT

Catalog Number	415670
Medical Device Problem Code	False Positive Result (1227)
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 notified biomérieux of obtaining false positive cefoxitin screen (oxfs) results for two strains while using the vitek® 2 ast-gp75 test kit (ref # 415670, lot#2750865203).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 any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for false positive cefoxitin screen (oxfs) results while using the vitek® 2 ast-gp75 test kit (ref # 415670 lot# 2750865203).The customer provided reports for the strains using gp75 lot 2750865203 using 8.01 software.Multiple attempts for customer strain submittal have been unsuccessful.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.On (b)(6) 2019 a field service engineer (fse) was dispatched for service, as troubleshooting with the customer and the application support team determined that the instrument was at fault.The fse inspected system and could not find reading errors.They replaced reader belts, reader ledges, motor pulleys, and the optics in both sections, and found loose motor pulleys in both sections during the removal and replacement of parts.The fse ran post service optics checks during initial tests, and completed all checks in the post service checklist.After service was performed, the customer reported a vast improvement with the reported oxsf inconsistent results.Vitek 2 ast-gp75 lot #2750865203 met final qc release criteria.The lot passed qc performance testing.

• Brand Name: VITEK® 2 AST-GP75 TEST KIT
• Common Device Name: VITEK® 2 AST-GP75 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8458214
• Report Number: 1950204-2019-00080
• Device Sequence Number: 354773
• Product Code: LON
• UDI-Device Identifier: 03573026437183
• UDI-Public: 03573026437183
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K053097
• 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): 05/31/2019

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: 04/09/2020
• Device Catalogue Number: 415670
• Device Lot Number: 2750865203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1