MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 COMPACT 30

Model Number	27530
Medical Device Problem Code	No Device Output (1435)
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 biomerieux of a missing isolate in association with the vitek® 2 compact 30 (ref.27530, serial number (b)(4) ), the vitek 2 gp id card (ref.21342, lot unknown) and software version 9.02.The customer obtained a low-discrimination result and stated when they tried to open the isolate record they obtained an error message stated ¿cannot find the isolate.¿ the customer restarted the system; the same error message was obtained when attempting to open the isolate record.It is unknown if the inability to review the isolate resulted in a delay of reporting results.Biomerieux has requested the customer data logs.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomerieux will initiate an internal investigation.
Additional Manufacturer Narrative
A customer in france notified biomerieux of a missing isolate in association with the vitek® 2 compact 30 (ref.(b)(4), serial number (b)(6)) and software version 9.02.The customer obtained a low discrimination result and stated when attempting to open the file an error message was obtained which stated ¿cannot find the isolate.¿ the customer turned the computer and instrument off then restarted the system; the same error message was obtained.It is unknown if the inability to review the isolate resulted in a delay of reporting results.The customer tested a gram positive identification (gp id) and ast p631 card.A root cause could not be determined.Anomaly record ar-20966 was created to support the gathering of new information going forward, to assist in determining root cause, if it recurs.All avenues of investigation activities have been exhausted for this complaint.If the issue were to recur, a new investigation will be opened.Investigator will gather the customer¿s database, log files, and determine the isolate of concern.The isolate will age out of the active workspace based on a system setting in general configuration.The maximum amount of time is 30 days.As a workaround, biomérieux recommended the customer: log out of all applications and shutdown the pc.Allow pc to reboot.Wait for core services to start.Log back in to the application to view isolate.If the issue reoccurs, perform a full system back up and contact biomérieux customer support.

• Brand Name: VITEK® 2 COMPACT 30
• Common Device Name: VITEK® 2 COMPACT 30
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11447029
• Report Number: 1950204-2021-00023
• Device Sequence Number: 14416266
• Product Code: LON
• UDI-Device Identifier: 03573026136789
• UDI-Public: 03573026136789
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/12/2021

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 Model Number: 27530
• 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: 02/03/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 11/12/2021
• 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