MAUDE Adverse Event Report: BIOMÉRIEUX INC. VITEK 2 COMPACT 15 - 27415

Model Number	27415
Medical Device Problem Code	Failure to Back-Up (1047)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description: a customer in france notified biomérieux of result not accessible in association with vitek 2 compact 15 (ref.(b)(4), serial number: (b)(4)).The customer reported obtaining an error message stating: "impossible to find the isolate or an error occurred when retrieving it".The pc was restarted twice, but the error was not resolved and result was not accessible.Biomérieux customer service recommended that the customer restart analysis.The results were delayed by more than 24 hours.There is no indication or report from the customer that this event led to any adverse event related to the patient's/user's state of health.An investigation will be initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of results not accessible in association with vitek 2 compact 15 (ref.27415, serial number: (b)(6).Investigation: complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend for the vitek 2 compact 15.Customer data log review: the logs did not contain any stack traces that indicated a definitive cause for the system to display the ¿isolate could not be found or an error occurred while retrieving it¿.This error may be displayed for multiple reasons.There were stack traces at on (b)(6) 2023 01:08:45 that highlighted the error with the backup.The discovery of this error prompted 2nd level support to request the event viewer files to further examine the events prior to and after the occurrence of the errors "the isolate could not be found or an error occurred while retrieving it" to rule out any underlying corruption present in the database.No evidence of any database / system corruption was present in the logs during the time of the reported issue with the 5 missing isolates.The logs and database review has provided no root cause for the "the isolate could not be found or an error occurred while retrieving it".Root cause: the root cause for the issue could not be identified.Conclusion: the investigation could not determine the root cause for the customer's back-up issue.At the time of the initial communication with the customer, local customer service (lcs) was able to successfully execute a manual backup.The customer repeated the id/ast testing for the 5 isolates successfully.The customer has not experienced any additional occurrences of this error.The system is now functioning as expected.The system will be monitored for any additional occurrences of this issue which will be escalated for further evaluation.

• Brand Name: VITEK 2 COMPACT 15 - 27415
• Common Device Name: VITEK 2 COMPACT 15 - 27415
• Manufacturer (Section D): BIOMÉRIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16744657
• Report Number: 1950204-2023-00003
• Device Sequence Number: 6726975
• Product Code: LON
• UDI-Device Identifier: 03573026220624
• UDI-Public: 03573026220624
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050002
• 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): 08/07/2023

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: 27415
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/07/2023
• 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