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

Model Number 414292

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: 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.Description of the issue: a customer in (b)(6) notified biomérieux of obtaining erroneous gram stain results using previ color gram instrument v2 - (reference 414292, serial number : #(b)(4)) for several strains.- e.Coli : violet / pink (variable) instead of pink (gram negative), - clostridium sporogenes : pink instead of violet (gram positive), - bacillus subtilis : pink / violet (variable) instead of violet (gram positive).The customer noticed that he had followed the wrong maintenance procedure before using the instrument.Moreover, the volume test and the pattern test failed.Consequently, the nozzles were changed and the line of crystal violet was flushed.Then, the customer performed repeat testing.However, he still obtained negative gram stain for clostridium sporogenes while the expected results was positive gram stain.The volume test was performed again and the results were outside the tolerance range: crystal violet <9ml.No patient impact has been reported as a consequence of the erroneous results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in china notified biomerieux of obtaining erroneous gram staining results using previ color gram instrument v2 - (reference (b)(4), serial number : #(b)(6) on several strains.Investigation: device history record and complaint database review: the investigator started by searching for other complaints recorded for a staining issue.There is no capa, nor non conformity on previ color linked with customer 's complaint.Based on cstat, there have been no ¿out of control¿ during the last three months.Instrument data review: the investigator determined that the pattern test, slide pattern test, and volume test results met specifications but was not optimal for iodine.Based on this findings, local customer service cleaned the instrument nozzles using the cleaning dip tubes sequence.After this cleaning dip tubes sequence, the slide pattern tests, pattern tests and volume tests were conform for all lines.Clostridium sporogenes was cultivated from liquid media (fluid thioglycollate medium).This kind of specimen (liquid culture media) is not part of the qualified specimen listed in the user manual previ color v2 ref.(b)(4).This specimen type has to be validated by the user.The cell suspensions qualified with previ® color gram instrument are : blood, bronchoalveolar liquid (bal), cerebrospinal fluid (csf), feces, sputum, vaginal swab, urine, wounds, pure strain isolate smears (gram positive, gram negative, yeast).Request n° is-5093 has been opened in helix in order to clarify the user manual previ color v2 ref.(b)(4) regarding ¿pure strain isolate smears¿ specimen description.This request will be evaluated for a future documentation update.Conclusion: according to the investigation, the customer's issue is due to non-optimal sample preparation/interpretation in conjunction with an instrument maintenance issue (b line did not meet specifications).Biomérieux local customer service will provide the necessary support and perform the required maintenance to avoid recurrence of the issue.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2
• 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: jeff scanlan ; 595 anglum road; hazelwood, MO
• MDR Report Key: 12480182
• MDR Text Key: 283625186
• Report Number: 8020790-2021-00189
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1