MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 HP RP5800 PC-WES7 - 413862

Model Number 413862

Device Problem No Device Output (1435)

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

Event Type  malfunction  

Event Description

Product intended use: the vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and clinically significant yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description of the issue: a customer from italy reported that he observed a communication issue within the vitek 2 system - vitek 2 hp rp5800 pc-wes7 (ref.413862) - serial number : (b)(4).The customer reported that cassettes were not visible in the vitek 2 software after loading them into the instrument.The customer stated there were no error messages to indicate a system issue.A field service engineer intervened at the customer¿s site and resolved the issue.The customer indicated they were unable to report results for more than 24 hours.

Manufacturer Narrative

A customer from italy reported that he observed a communication issue within the vitek 2 system - vitek 2 hp rp5800 pc-wes7 (ref.(b)(4)) - serial number : (b)(6).The customer contacted local customer service to report that they were unable to see the data for a cassette just entered.The system was currently at software version 8.01.The communication between the pc and the instrument was ok.Neither the requested universal troubleshooting form nor the logs were provided for this investigation.Therefore, a potential root cause related to the complaint could not be determined.Per the complaint information, the issue was resolved by local service, however additional details were not provided.

• Brand Name: VITEK 2 HP RP5800 PC-WES7 - 413862
• Type of Device: VITEK 2 HP RP5800 PC-WES7 - 413862
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12396021
• MDR Text Key: 280708217
• Report Number: 1950204-2021-00073
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1