MAUDE Adverse Event Report: PREVI COLOR GRAM INSTRUMENT V2 - 414292

Model Number 414292

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

Intended use: 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 description of the issue: a customer ireland notified biomérieux of obtaining an incorrect gram staining when using the previ® color gram (reference 414292, serial number# (b)(4)).The customer has reported having obtained pink gram positive bacteria instead of purple colonies.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.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context: a customer in ireland notified biomérieux of obtaining an incorrect gram staining when using the previ® color gram (reference 414292, serial number# (b)(6)) indeed, the customer has reported having obtained pink gram positive bacteria instead of purple colonies.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.This device is an original equipment manufacturer (oem) product, and biomérieux distributes it for the vendor elitech.The customer contacted biomérieux for this technical complaint, the vendor has been notified of this complaint by biomérieux's global customer service, and the scope of this investigation is the manufacturing vendor's investigation for this device serial number.Investigation results: complaint analysis: a complaint analysis has been performed and did not indicate any systematic quality issue related to this complaint.There is no trend related to this complaint during the investigated period.Investigations based on the complaint information content and troubleshooting: a field service engineer went on site and changed the valve board and carried out volume and pattern tests successfully.In addition, during troubleshooting, it has been observed that for drying step, customer put slides at 60 degrees for minimum one hour, one hour is long, it could have an alteration of certain constituents, in particular the bacterial wall.Conclusion: the suspected root cause of the related issue is an operator error.Indeed, the instrument maintenance was not followed properly and preanalytical steps were not non-optimal.It has been recommended to the customer to: perform maintenances described in the previ color user manual (daily, weekly and monthly).To avoid too abrupt drying, at too high temperature because it could lead to an alteration of certain constituents, in particular the bacterial wall.Consequently, too abrupt drying could have a negative impact on the staining performances.The use of the previ color gram v2 fixation setting is then recommended to avoid any issue.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer Contact: pauline previtali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15907250
• MDR Text Key: 305629646
• Report Number: 8020790-2022-00110
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• 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