MAUDE Adverse Event Report: BIOMERIEUX SA 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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of bad coloration issues when testing strains with the previcolor® gram instrument v2 (ref.414292 ¿ serial number: (b)(4)).The customer first noticed the issue after obtaining incorrect identification results using their vitek® 2 instrument.The customer stated the incorrect identification results were due to incorrect gram stain results.The customer then performed a gram stain using their previcolor® gram instrument v2 and a gram negative bioball® escherichia coli strain.The gram stain result was purple in color indicative of a gram positive result.Biomerieux customer service requested information regarding impacted patient results but has not received a response.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in france regarding bad coloration issues when testing strains with the previcolor® gram instrument v2 (ref.(b)(4)¿ serial number: (b)(6).The customer first noticed the issue after obtaining incorrect identification results using their vitek® 2 instrument.The customer stated the incorrect identification results were due to incorrect gram stain results.The customer then performed a gram stain using their previcolor® gram instrument v2 and a gram negative bioball® escherichia coli strain.The gram stain result was purple in color indicative of a gram positive result.A biomérieux internal investigation has been completed with the following results: there is no capa, no non conformity on previ color linked with customer 's complaint.Instrument return and repair: the previ color v2 instrument was returned for investigation and repair.No issues were observed when the instrument was received.As a preventative action, the valve distribution board of the reagents, all the nozzles and all the inserts were replaced.After replacement, volume tests and task tests conformed to specifications.The instrument functioned as expected.Suspected root cause : unknown as the issue was not observed when the instrument was received.The defective spare part causing the staining issue was not identified.See.

• 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: 9863020
• Report Number: 8020790-2020-00036
• Device Sequence Number: 19621424
• 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): 05/27/2020

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: 02/21/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1