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

Catalog Number 421648

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

A customer from the united states reported she cannot access web client from their laboratory computer nor from the vitek® 2 computer.The vitek 2 system pc software was restored to the most recent database available (october 23), which was three (3) days old.The system was fully functional again with isolates from 10/23.Data for patient isolates being processed in the vitek 2 reader at the time of failure were lost.These patient isolates will require re-processing or testing via alternate method, constituting a delay >24 hours.There is no indication or report from the customer that the loss of data led to any adverse event for any patient.

Manufacturer Narrative

A customer from the usa reported she cannot access web client from their laboratory computer nor from the vitek® 2 computer.As part of the troubleshooting, the system was rebuilt using the data backup file from 23oct2021.The system was fully functional again with isolates from 10/23.Customer database and logs were requested.The customer was unable to release the data per facility management.Without the software log folder and data backup file the root cause can not be determined.If additional evidence from the date of occurrence is provided, this investigation can be reopened.

• Brand Name: VITEK 2 V8.01 HP RP5810 PC WES7 - 421648
• Type of Device: VITEK 2 V8.01 HP RP5810 PC WES7
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12868386
• MDR Text Key: 287329731
• Report Number: 1950204-2021-00083
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 421648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1