MAUDE Adverse Event Report: BIOMERIEUX SA PREVI COLOR GRAM INSTRUMENT V2; PREVI® COLOR GRAM INSTRUMENT V2

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
A customer in (b)(6) notified biomerieux of obtaining an incorrect gram stain result in association with the previ® color gram instrument (ref.414292, serial # (b)(4)) when testing a patient blood culture sample.The customer stated that they observed gram negative bacteria which were purple in color on one side of the slide.However, on the other side of the slide, the gram negative bacteria are pink.A gram positive result was initially provided to the treating clinician; however, the correct gram negative result was provided to the clinician the same morning approximately three and a half hours later.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomerieux has initiated an internal investigation.
Additional Manufacturer Narrative
Investigation: review of the historical complaint database to identify any other reports similar to this customer's issue determined one other similar complaint was recorded - e.Coli stained as gram positive instead of gram negative with previ color v2 (case (b)(4) from france).No historical capas nor non conformities against previ color gram are linked with customer 's complaint.During the investigation/trouble shooting process, the investigator determined: the previ color settings have been validated by biomérieux, and comply with specifications.The nozzles maintenance appeared to be well done.The preventive maintenance was documented.The alcohol used by the customer does not meet bmx specifications.The customer uses ethanol 96%, and current recommendation for previ color gram alcohol reagent is ethanol or methanol at 99.8%, or reagent grade alcohol.Reagent grade alcohol should meet the following specifications: 1.90% ethanol.2.Approximately 10% of isopropyl alcohol and/or methanol.3.0.5% water.4.No ketones.70% ethanol or methanol can be used to wipe down the carousels or instrument during routine maintenance.The customer sent their previ color gram to the biomérieux ¿french repair workshop¿.Several parts were exchanged.The instrument was returned to the customer laboratory and the staining for gram positive and gram negative now conforms to expectations.As several parts were exchanged, it is unknown which specific part exchange is responsible for resolving the issue.It was not possible to conclude on the following topics due to lack of information provided by the customer: pre-analytic step, loading slides step, running cycle step, reagents trend analysis, system.Thus, the root cause remains unknown, although expected to be one of the parts exchanged in the repair shop.No capa is required.There is no capa, no non-conformity on previ color gram linked with customer 's complaint.Local customer service advised the customer to routinely perform the following cleaning dip tubes sequence: 1.Perform the removing reagent bottles procedure.2.Ensure the ends of all the dip tubes are in containers of approved alcohol.3.Remove the nozzles.4.Place an empty carousel in the instrument and shut the lid.5.Press maintenance.6.Press 60 sec prime.7.Press abcde.The instrument will pump alcohol through each reagent line for 60 seconds and will remove all the stain and water left in the pumps.Then wait 30 minutes.Remove the alcohol containers and connect the dip tubes with reagent bottles.Prime all channels for 60 seconds.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2
• Common Device Name: PREVI® COLOR GRAM INSTRUMENT V2
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 11604157
• Report Number: 8020790-2021-00072
• Device Sequence Number: 17058768
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 03/04/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1