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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states reported that patient test cards associated with the vitek® 2 xlr module colorm 110v did not show up in the software.Cards loaded into the instrument on (b)(6) 2018 and (b)(6) 2018, did not show up in the software.The data folders were empty so the instrument and pc were rebooted without error, and the data folders remained empty.The customer mentioned that eleven cards were loaded on (b)(6) 2018, and only one card was terminated in each carousel, with four cards in the waste tray.In the diagnostic terminal, cards loaded on (b)(6) 2018 did not show in carousels, and only showed one terminated in each carousel.The customer reported that patient results were delayed greater than 24 hours from the expected reporting time frame.The customer stated that no incorrect result was reported.There is no indication or report from the hospital or treating physician to biomérieux that the delayed result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This investigation was initiated in response to a customer complaint that patient test cards associated with the vitek® 2 xlr module colorm 110v did not show up in the software.Following a field service engineer (fse) site visit (b)(6) 2018, cards loaded later that day did not appear in the vitek 2 systems (v2s) software.Preliminary troubleshooting by local customer service (lcs) found no messages in the com 5 or com 7 folder.The provided instrument log (logs_and_history) contained data relative to the complaint event.It showed that the instrument was functioning normally and no errors occurred when three cassettes were processed on (b)(6) 2018 (two with cassette id "qc"; one with cassette id "wnd").The associated test cards ejected normally on (b)(6) 2018.Of those test cards there were nine processed as cassette id "wnd" which could not be found in the provided vitek 2 system software database.This was because the provided database backup was taken (b)(6) 2018, and any relevant information had aged off normally.Therefore, it is not possible to perform further investigation to determine why test cards loaded 03dec2018 did not appear in the vitek 2 systems software.

• 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: 8212655
• Report Number: 1950204-2019-00001
• Device Sequence Number: 1987899
• Product Code: LON
• UDI-Device Identifier: 03573026145842
• UDI-Public: 03573026145842
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050002
• 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): 03/07/2019

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: 12/04/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1