MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 COMPACT 60; VITEK® 2 COMPACT 60

Model Number 27560

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of an issue where therapeutic corrections (tc) were not being sent to laboratory information system (lis) using the vitek® 2 compact (reference # 27560, serial # (b)(4)).User complained about an hl7 connection with the lis where the therapeutic corrections were not sent to lis.They saw that only non-expertized results were sent to lis instead of expertized results.They indicated that no wrong results were given to the physician and that since the beginning of this issue they verified each result manually on the lis until they can find a solution.The expert unit was able to recreate this issue.They determined that antibiotics with a therapeutic correction are not being sent to the lis as expected.When isolate results are sent to the lab information system (lis) via hl7 for the first time, there is no problem.However, if the isolate is sent more than once to the lis, then the system does not send the expertised (corrected) interpretation result.This is true for all cases of therapeutic corrections: phenotype, forcing rule, and biologic correction.A physician may not realize that an antibiotic should not be used.For clarification, the mic values of the results will not change but it is possible that the interpretation may change if it is associated with one of the listed therapeutic corrections listed above.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in thailand regarding an issue where therapeutic corrections (tc) were not being transfered to the laboratory information system (lis) using the vitek® 2 compact (reference # 27560, serial # (b)(6).The customer reported their hl7 connection with the lis was not sending therapeutic corrections to the lis.They observed that only non-expertized results were sent to lis instead of expertized results.Local customer service (lcs) provided data backup from the customer¿s system, logs, and examples as requested by global customer service (gcs) for the complaint.The root cause of the event is software design specifications for hl7-compliant resent messages.The design/implementation is hl7 compliant and compliant with biomérieux specification use case as well; however, the biomérieux specification for an hl7-compliant implementation does not specify what to send in an hl7-compliant "corrected results" message.More specifically, it does not direct how to handle therapeutic corrections in the context of hl7 results messages.The following are actions as a result of this investigation: an internal capa was initiated, a field safety corrective action fsca-5026 was issued 28-jan-2021, correct the hl7 issue via maintenance update 9rm2, an internal specification document will be created to ensure isolate results (with or without therapeutic corrections) that are ¿reanalyzed¿ will be re-sent to the lis, re-publish the hl7 connectivity and specification service manuals to the gcs portal and technical library.

• Brand Name: VITEK 2 COMPACT 60
• Type of Device: VITEK® 2 COMPACT 60
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10901371
• MDR Text Key: 247128803
• Report Number: 1950204-2020-00205
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026136796
• UDI-Public: 03573026136796
• Combination Product (y/n): N
• PMA/PMN Number: K050002
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27560
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1