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

Model Number 27560

Device Problem Computer Software Problem (1112)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) reported that vitek® 2 gn id and ast-gn86 cards were stuck in preliminary status in the vitek 2 compact 60 (ref.27560) instrument when testing patient samples.The customer stated there was no error message and results were not complete.After trying to re-run cards at biomérieux's request, the customer stated that the system was not functional.A biomérieux field engineer intervened at the customer site, re-installed vitek 2 v8.01 systems software and the customer reported that vitek 2 was working perfectly.The customer reported that the patient results were delayed by more than 24 hours.No incorrect result was reported.There is no indication or report from the hospital or treating physician to biomérieux that the delayed results led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the (b)(6) regarding vitek® 2 gn id and ast-gn86 test results that remained in preliminary status in the vitek 2 compact 60 (ref.27560).Biomérieux investigation was conducted.History: · on (b)(6) 2019, customer reported that several of their ast-gn86 isolates remained in the preliminary state and could not be finalized.Local customer support (lcs) asked the customer to re-process the specimens.· on (b)(6) 2019, customer reported that their vitek 2 systems software was completely non-functional.· on (b)(6) 2019, a biomerieux field application specialist visited the customer site and applied the following steps: backed-up, exported and archived all data.Backed-up all vitek 2 systems software configurations.Re-installed vitek 2 systems version 8.01 software.Re-configured software settings to original user settings.Created a manual back-up.Created a full system image back-up.Ensured system functioning normally before leaving.· on (b)(6) 2019 the biomerieux field application specialist contacted the customer and confirmed that the system was working as expected.· on (b)(6) 2019 the biomerieux field application specialist reported the following impacts from the 23aug2019 occurrence: 15 patients samples held at preliminary status for 7-8 days.Identification (id) cards were not impacted; only ast cards remained in the preliminary state.No knowledge of individual patient diagnosis, clinical symptoms or clinical impact.No evidence or details (e.G.Lab reports, data files) of the reported issue were provided by the customer to biomérieux due to data protection policies at the customer site.Without specific details of the occurrence, the root cause cannot be determined.No further investigation is possible.

• Brand Name: VITEK® 2 COMPACT 60
• Type of Device: VITEK® 2 COMPACT 60
• 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 ; 3147318694
• MDR Report Key: 9100800
• MDR Text Key: 219200853
• Report Number: 1950204-2019-00284
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026136796
• UDI-Public: 03573026136796
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2019
• 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: Unknown
• Patient Sequence Number: 1