MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 V8.01 HP RP5810 PC WES7 - 421648

Model Number 421648

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of experiencing a delay of >24 hours in reporting patient results due to an error where cassette data could not be found in association with the vitek® 2 v8.01 hp rp5810 pc wes7 (ref (b)(4), serial (b)(4).The customer reported having an error associated with the cassette.The customer thought that they had corrected the issue and reloaded the cassette.The next day, the customer went to check the results for the cassette, but the cassette was not showing in the vitek 2 application.Results would be delayed > 24 hours due to the need to repeat testing.There is no indication or report from the customer that this issue led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of experiencing a delay of >24 hours in reporting patient results due to an error where cassette data could not be found in association with the vitek 2 v8.01 hp rp5810 pc wes7 (ref 421648, serial czc9147zx1).Global customer service (gcs) requested logs and a database from the customer system, along with the timestamp of the cassette deletion, if applicable, and a list of lab ids from the cassette that was not found in the software.Local customer service (lcs) reported that the customer stated that it would not be possible to provide the information or logs requested by gcs.Furthermore, lcs noted that the issue had not occurred again and indicated that no logs would be provided by the customer.It was not possible to propose a definitive root cause for this complaint due to insufficient information being provided.The information provided by the customer suggests that the user did not correctly address a cassette error issue, but the circumstances of the issue were not described.The customer repeated the testing and no further issues were observed.Complaint trending performed by gcs did not identify this issue as a trend for this product.

• Brand Name: VITEK 2 V8.01 HP RP5810 PC WES7 - 421648
• Type of Device: VITEK 2 V8.01 HP RP5810 PC WES7 - 421648
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10457114
• MDR Text Key: 206136458
• Report Number: 1950204-2020-00151
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 421648
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1