MAUDE Adverse Event Report: BIOMÉRIEUX SA PREVI¿ COLOR GRAM (VERSION2); PREVI COLOR GRAM INSTRUMENT V2 - 414292

Model Number 414292

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of obtaining a discrepant result when testing a patient isolate with the previ® color gram instrument v2 (ref.414292).The customer stated that previ® color gave a result of gram negative compared to the manual staining method which gave gram positive result.The customer did not give any information regarding the identification of the strain.The customer stated the gram negative result was reported to the treating physician, but confirmed the discrepant result had no adverse impact to the patient¿s state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An internal investigation was initiated following the notification of conflicting gram stain results between the previ® color with a result of gram negative and a manual gram stain with a result of gram positive.The identification of the organism was requested but not provided.A biomerieux local field service engineer (fse) visited the customer site on 20-dec-2019 and noted the nozzles needed cleaning, fixation was off, and the smearing of sample was not optimized stating the sample was too thick.Pattern and volume tests were performed on the instrument; both tests obtained passing results.Root cause(s): user error: daily maintenance not well done, user error: non-optimal specimen preparation.The system is now operating as intended.See section h10.

• Brand Name: PREVI¿ COLOR GRAM (VERSION2)
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• MDR Report Key: 9434273
• MDR Text Key: 219790494
• Report Number: 8020790-2019-00073
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1