MAUDE Adverse Event Report: BIOMÉRIEUX SA PREVI¿ COLOR GRAM (VERSION2); 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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 8020790-2019-00073
• Device Sequence Number: 2597034
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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
• Operator of Device: Health Professional
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1