MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK® 2 HP RP5810 PC WES7

Catalog Number 421648

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a missing patient isolate in association with the vitek® 2 hp rp5810 pc wes7 (ref.421648, serial number (b)(4)) and software version (b)(4).The customer obtained an internal system error (ise) in the isolate detail view; multiple attempts to restart the software did not resolve the issue.The customer stated since they could not access the detail view they could not discern if any alternative tests methods were performed for a patient isolate.Therefore, they could not exclude a delay of >24 hours in reporting patient results.Although a potential exists for delay of >24 hours in reporting results, there is no indication or report from the laboratory that the missing result/delay led to any adverse event related to the patient's state of health.

Manufacturer Narrative

A customer in germany notified biomerieux of a missing patient isolate in association with the vitek® 2 hp rp5810 pc wes7 (ref.421648, serial number (b)(6)) and software version 9.02.The customer obatined an internal system error on "isolate detail view" when attempting to access the isolate.The root cause was determined to be related to the design of the vitek 2 software version 9.02.Advanced expert system¿ (aes) analysis is not robust enough to process missing information (e.G.Beta-lactamase offline-test result, or missing antibiotic results like oxacillin) while trying to perform phenotypic deduction.When the vitek® 2 systems software application receives an unexpected (empty) result for the aes analysis engine (depending on the isolate¿s card product type configuration), the isolate will remain in the preliminary state and will not be automatically sent to any external communication systems (lis).Biomerieux recommends the following workarounds for this specific issue: disable the configuration options for ¿enable deduction by phenotype¿ and "enable deduction without expertise¿ in the aes configuration for the aes parameter set(s) and reanalyze the impacted isolate(s).Or remove antibiotics from the ¿antibiotics to deduce¿ list defined for each of the ast-gp card(s) and reanalyze the impacted isolate(s).This information was provided to the customer on 27dec2021.

• Brand Name: VITEK® 2 HP RP5810 PC WES7
• Type of Device: VITEK® 2 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: 12722275
• MDR Text Key: 284299864
• Report Number: 1950204-2021-00080
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103752
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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
• Date Manufacturer Received: 12/21/2021
• 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