MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 V7.01 HP RP5810 PC WES7 - 420855

Model Number 420855

Device Problem Missing Test Results (3267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of experiencing an issue in which data was missing for cassettes after performing testing with their vitek® 2 v7.01 hp rp5810 pc wes7 (ref 420855, serial (b)(4)).The customer reported that they create vitek® 2 cassettes with the vitek® ms prep station.The customer set up virtual cassettes with cards on position 2, 4, 6, and 8 (4 different patients).The vitek® 2 incubated the cards without error, but the virtual cassette displayed in the vitek® 2 software only showed the card in position 8.The customer had to perform repeat testing for the cards that were in position 2, 4, and 6 and this led to a delay of > 24 hours in reporting results for three (3) patients.There is no indication or report from the customer that this event has led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This investigation was initiated due to a complaint from a customer in france using vitek 2 systems (8.01).The customer created two vitek 2 cassettes on (b)(6) 2021 with vitek ms prep station as virtual cassettes.One cassette had cards in position 2, 4, 6 and 8.The vitek 2 incubated cards without error, however the customer noticed this cassette in vitek 2 systems software only had one card in position 8.The remaining cards in positions 2, 4 and 6 were not displayed.A total of five (5) cards were reported a missing between the two cassettes.The customer processed new cards on (b)(6) 2021 which delayed results >24 hours.The root cause is user error.The cards reported as missing from both cassettes were determined to have been deleted by the customer thereby also removing the cards from the cassette.No corrective/preventive actions are required as the system is working as expected.

• Brand Name: VITEK 2 V7.01 HP RP5810 PC WES7 - 420855
• Type of Device: VITEK 2 V7.01 HP RP5810 PC WES7 - 420855
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11562700
• MDR Text Key: 254392710
• Report Number: 1950204-2021-00026
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: N50510S082
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420855
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1