MAUDE Adverse Event Report: BIOMERIEUX, INC. COMPUTER VITEK 2 HP RP5700 R; COMPUTER VITEK® 2 HP RP5700 R

Model Number W0452R

Device Problem Missing Test Results (3267)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of experiencing delays in reporting of results when testing with the vitek® 2 system (computer vitek 2 hp rp5700 r - reference w0452r, serial # (b)(4)) and software version (b)(4).The customer reports that after the software loads, the instrument does not allow reading of any antibiogram for processed cards.There were no instrument errors.The cards were not displayed in either cassette management nor in esmi management.A field service engineer (fse) was dispatched to the site and performed maintenance on the vitek 2 system.He corrected some errors on the system then rebooted the system.The customer could then observe all the id and ast cards.The reset of the system resolved the system error.The customer reported a delay of greater than 24 hours in reporting results.There is no indication or report from the laboratory that the delayed results led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer in italy who reported that their antimicrobial susceptibility test (ast) results were not visible in the vitek® 2 systems application even though the cards had been processed by the reader.No instrument errors were observed.Customer did not provide information regarding which cards were missing from the cassette view, nor when the card results were determined missing.It was impossible to perform an analysis to determine root cause for the complaint because no supporting data was provided by the customer to help determine the state of the system when the problem occurred.The correction (performed by fse) of rebooting the customer¿s system was successful and the problem was corrected.There are no corrective/preventive actions as the root cause could not be determined.

• Brand Name: COMPUTER VITEK 2 HP RP5700 R
• Type of Device: COMPUTER VITEK® 2 HP RP5700 R
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11140612
• MDR Text Key: 255901343
• Report Number: 1950204-2021-00008
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: K050002
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W0452R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1