MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 XLR MODULE COLORM 110V

Model Number	27222R
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was initially submitted following notification by a customer in the united states regarding vitek® 2 card data missing when testing patient isolates with the vitek® 2 xlr module colorm 110v.The customer stated that some cards are not displaying in the vitek® 2 application.Biomérieux investigation was conducted.The vitek 2 systems software log files and database submitted by the customer were reviewed by biomérieux.The investigation concluded that the instrument encountered multiple transport and carousel errors, which resulted in the termination of 17 test cards.This caused these cards to not be loaded into the instrument and terminated the cards.The cards were successfully processed into the vitek 2 systems software as preliminary isolates with no results.The customer's report of missing cards could not be confirmed with the submitted vitek 2 systems software log files or database.All instrument messages sent by the customer's two (2) instruments were successfully processed into the vitek 2 systems software without error.Some cards that are indicated in the vitek 2 systems log files are currently not present in the customer's software or database; the cause of these non-existent cards is the customer's deletion of the isolate and associated card(s).It is unknown if these deleted cards are among those alleged by the customer to be missing.No vitek 2 systems anomaly was found to be associated with the customer's reported loss of card data.The issue could not be confirmed as part of a review of the v2s software and instrument log files or database.
Event or Problem Description
A customer in the united states notified biomérieux of vitek® 2 card data missing when testing patient isolates with the vitek® 2 xlr module colorm 110v.The customer stated that some cards are not displaying in the vitek® 2 application.The customer may load a full cassette, but some cards are not showing up in the software the next day when the results are checked.The issue led to a delay of >24 hours for some test results, but no incorrect results were obtained and there was no patient injury or inappropriate treatment due to the delay.The customer did not provide the number of patients for which test results were delayed.After the initial complaint, the customer began monitoring for any additional missing card data.After four weeks of monitoring, there was not a recurrence of the issue.A biomérieux internal investigation will be initiated.

• Brand Name: VITEK® 2 XLR MODULE COLORM 110V
• Common Device Name: VITEK® 2 XLR MODULE COLORM 110V
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9152594
• Report Number: 1950204-2019-00294
• Device Sequence Number: 11458767
• Product Code: LON
• UDI-Device Identifier: 03573026145842
• UDI-Public: 03573026145842
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: N50510 S082
• 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): 12/12/2019

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 Model Number: 27222R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1