MAUDE Adverse Event Report: BIOMÉRIEUX SA PREVI COLOR GRAM INSTRUMENT V2

Model Number 414292

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Product description: the previ® color gram has been designed to perform automated gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics.Complaint description: a customer in france complained after having observed incorrect gram staining test results when using the previ® color gram (reference (b)(4), serial number (b)(4).The customer said that since seven months, they had obtained in several instances gram positive results instead of gram negative for microoganisms isolated from urine samples.The customer mentioned that some times they had observed the same issue with microoganism isolated from blood samples.The customer said that no incorrect gram staining results were obtained with their second previ color instrument.The customer states that no incorrect gram staining results were reported to a physician.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.

Manufacturer Narrative

Following the staining issues observed by the customer when using their previ color gram instrument serial number (b)(6), an investigation has been carried out.The local field engineer (fe) was at customer site and replaced waste tubing.The fe performed the following tests: volume test, and the nozzle volume was within the expected range.Pattern test and no anomalies were found.Launch of qc slide staining cycle: staining were conform for bacilli gram negative and bacilli gram positive.Slide pattern tests were performed and they were conform.The previ color gram instrument is working as per intended.No instrument malfunction has been observed.The customer staining setting was checked and it was found that only one staining setting is used for all kind of specimen.Biomérieux¿s recommendations are to set specifics staining program cycles by sample type (i.E.Create and use one specific program for vaginal sample, create and use one specific program for blood culture sample, same for other samples types) and with one type of sample per carousel.As indicated in to the user manual - loading paragraph.The fe created a new staining program for urine samples.Blind color tests with known samples were performed and the customer was satisfied with the results obtained with their previ color gram instrument.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile ; FR
• Manufacturer Contact: stefania ciranda ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16458449
• MDR Text Key: 310515608
• Report Number: 8020790-2023-00012
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1 EXEMPT
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414292
• Device Catalogue Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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