MAUDE Adverse Event Report: BIOMÉRIEUX SA PREVI COLOR GRAM INSTRUMENT V2

Model Number 414292

Device Problem Unexpected Color (4055)

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

Event Type  malfunction  

Event Description

Intended use: the previ® color gram is an in vitro diagnostic medical device for professional use only.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 with biomérieux previ® color gram reagents only.Issue description: a customer in sweden notified biomérieux of a staining issue in association with previ color gram instrument v2 ((b)(4)).Customer reported having gram negative bacteria inappropriately stained blue.Customer has not used instrument for staining in recent months due to staff shortage, so no time for validation.They have used the instrument with empty slides three times per week and performed daily, weekly and monthly maintenance.When the customer started to stain samples, they were too blue.The customer changed all nozzles; however, no change in the staining.Biomérieux global customer service (gcs) asked customer the following questions : name of the strain of the strain involved; specimen type (blood culture, isolated colonies on plates, urine); if blood culture, which reference and supplier name.At the time of assessment, the customer has not yet answered.The customer said all pattern tests look good, volumes are within normal (except water 8.5); the volume 8.75 was noted during installation.Gcs added regarding the volume of water measured (8.5 ml) that it is not compliant and needs to be adjusted.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation has been initiated.

Manufacturer Narrative

Context: a customer in sweden notified biomérieux of a staining issue in association with previ color gram instrument v2 (ref.(b)(4), serial number (b)(6)).The customer reported that there was an issue on gram negative which are staining blue and heterogenous staining (mix of violet and pink bacilli for gram negative strains).The issue is observed after a long storage of the instrument without use during the fall/winter due to shortage of staff.Customer reported the same issue after just one week after installation, this was solved with b-line flush and replacement of all nozzles.This device is an original equipment manufacturer (oem) product, and biomérieux distributes it for the vendor elitech.The customer contacted biomérieux for this technical complaint.** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation: the issue is observed after a long storage of the instrument without use during the fall/winter due to shortage of staff.There is no indication on how the instrument was stored and if long storage recommendations were applied.It could be the cause of the issue = ¿improper long storage conditions¿.If the instrument is inactive for more than a week, the user must perform the long-term storage procedure.This will prevent nozzles from clogging when the machine is reactivated.However, it was not possible to confirm this.During the monthly maintenance, customer change nozzles to the set they have cleaned the previous month and did a decontamination of reagent d-bottle.Even by changing nozzles with new ones, the staining didn´t improve.Finally, biomérieux local customer service (lcs) decided to replace the instrument at the customer site and therefore to stop any troubleshooting on this instrument with the customer; this instrument has been prepared for long term storage, decontaminated and packed.All parameters were conformed after verification by lcs (volume test, pattern test, ¿); based on this, no further investigation on this instrument serial number (b)(6) was required.In addition, lcs observed discrepant volume results between 5l bottles and 500ml bottles.Based on this finding, it was decided to open a change ((b)(6)) to improve the user manual in order to add a procedure for adjusting the pumps.For information: - the impact on the staining could be due to the size of the smear (must be thin), the location of the smear on the slide (must be in the center of the slide), the age of the ¿positive blood culture¿ (exponential phase, stationary phase, ¿), the species specificities (for example neisseria and acinetobacter are known to concentrate fuschin and can appear ¿falsely purple¿, species can have variable gram coloration, organisms with specific morphology like very small gram negative bipolar bacilli, ¿) - there was no complaint against reagents used by the customer from lots a l14515, b l14715, c l56205, a l14415, b k01946 and c l20317.Conclusion: investigations performed did not allow to find the real cause of the issue.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile ; FR
• Manufacturer Contact: céline lacroix gimon ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16493910
• MDR Text Key: 310794379
• Report Number: 8020790-2023-00013
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: C1 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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