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 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.A customer in france notified biomérieux of obtaining non-homogeneous gram staining when using the previ® color gram (reference number and serial number: (b)(4)).The customer has reported having obtained non-homogeneous color including positive and negative gram staining with no color.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 discrepancy was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context: a customer in france notified biomérieux of obtaining non-homogeneous gram staining when using the previ® color gram (reference (b)(4) , serial number#(b)(6).Indeed, the customer has reported having obtained non-homogeneous color including positive and negative gram staining with no color.Investigation results: complaint analysis: the complaint analysis did not indicate any systematic quality issue related to the case.Investigations based on the complaint information content and troubleshooting a field service engineer (fse) visited the customer site and observed that volume test were not in compliance for lines a, b, dr, df and e.The fse cleaned the nozzles and adjusted the pumps in order to obtain the correct values for the volume tests.Additional tests after volume adjustment : -priming conform.-volume test conform.-pattern test conform.-launch of several control slides by the customer and staining were compliant.Conclusion: the suspected root cause of the incorrect gram staining is a volume issue linked to a pump non optimal adjustment.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15996060
• MDR Text Key: 305912633
• Report Number: 8020790-2022-00113
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1