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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) notified biomérieux of a gram staining issue in association with their previ color® v2 instrument ref.414292, serial number (b)(4).The customer stated all samples tested using their previ color® v2 instrument obtained a negative gram stain result.The customer confirmed the decolorizer used was medical alcohol and that they adjusted the decolorizer levels.A biomérieux field service engineer (fse) visited the customer site and performed nozzle maintenance, pattern test, and volume test.No issues were noted.There is no adverse patient impact.The customer confirmed manual gram stains were performed to confirm any questionable results.No incorrect results were reported to the treating physician.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
The investigator reviewed the complaints database for other reports for a staining issue.No capas nor non-conformities for previ® color are linked with the customer's complaint.As there is no information regarding the samples types tested, it is not possible to determine similar complaints have been recorded.Biomérieux is unable to make any conclusions on the following topics due to the partial information provided: pre-analytic step, loading slides step, running cycle step, reagents trend analysis, system and setting local service visited the site and did not find any problems.The field service engineer (fse) performed nozzle maintenance, pattern tests, volume tests and a verification of the staining quality preparations.After fse visit, previ color was working properly.Root cause analysis unknown corrective or preventive actions no capa is required.There is no capa, no non-conformity on previ color linked with customer's complaint.

• 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: 11353122
• Report Number: 8020790-2021-00014
• Device Sequence Number: 4132669
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/21/2021

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: 12/22/2020
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1