MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 MODULE EU

Model Number 27202

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

A customer in (b)(6)notified biomérieux of isolates missing while using the vitek® 2 module eu (reference # 27202, serial # (b)(4)).On (b)(6) 2021, the customer was unable to locate five (5) patient isolates in the software that were launched the previous day ((b)(6) 2021).Biomérieux local customer service (lcs), remotely logged into the customer's software.The isolates could not be found.There was one error on the system that informed the customer that the memory button of the cassette was having an error.It is unknown if this was the same cassette that has the ¿missing¿ results because the customer does not label their cassettes with identifiers: the customer set up the cards again on (b)(6) 2021 to ensure the patient¿s would receive test results.Therefore, there was a delay greater than 24 hours in reporting the patient results.There is no indication or report from the laboratory that the delayed results led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in france notified biomérieux of isolates missing while using the vitek® 2 module eu (reference # 27202, serial # (b)(6)).On (b)(6) 2021, the customer reported they were unable to locate five (5) patient isolates in the software (launched the previous day - (b)(6) 2021).The root cause of this occurrence is due to user error: failure to setup the isolates again after a cassette memory button failure occurred.The vitek 2 instrument user manual (041387-02-2n-2020-04) section 8 ¿ appendix troubleshooting documents actions related to a failure of the cassette memory button.The customer was contacted on (b)(6) 2021 and the customer verified that they have not seen a recurrence of the issue since the initial complaint.

• Brand Name: VITEK® 2 MODULE EU
• Type of Device: VITEK® 2 MODULE EU
• 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: 11439782
• MDR Text Key: 280450552
• Report Number: 1950204-2021-00022
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N50510/086
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1