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

Model Number	414292
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the previ® color gram is an in vitro diagnostic medical device for professional use only.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 with biomérieux previ® color gram reagents.Issue description: a customer in united kingdom notified biomérieux of a staining issue in association with previ color gram instrument v2 ref.414292, serial number (b)(4).Customer reported having problems with the incorrect color presentation; previ color slides coming out as gram negative but should be gram positive.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
Context: a customer in united kingdom notified biomérieux of a staining issue in association with previ color gram instrument v2 (ref.414292, serial number (b)(6)).Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results.Issue resolved by field service engineer (fse) intervention at customer site.Fse went on site and performed several actions: - replaced valve pcb due to possible issues with a and c valves, as recently replaced b valve.Noticed b line nozzle connector slightly loose.- replaced all nozzles with new ones from maintenance kit.- performed prime run, clean run and then pattern tests and volume tests after prime.- customer performed test with samples: test performed ok - noted also slight pitting underneath nozzles on drum body.Based on these findings, it was not possible to define the exact cause of the issue; it could be due to the nozzles, the valves or nozzle connector.Conclusion: root cause analysis was unknown, investigations performed at customer site and elitech site did not allow to find the exact cause of the issue.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Common Device Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: céline lacroix gimon ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14889665
• Report Number: 8020790-2022-00073
• Device Sequence Number: 5089583
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown