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

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 has been designed to perform automated gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics.Issue description: a customer in france notified biomérieux of obtaining incorrect gram stains, both positive when expected is negative and negative when expected is positive associated with previ color gram instrument v2 (ref.414292, (b)(4)).The customer noted that this issue has been ongoing since obtaining the instrument in october of 2022 and that the slides are not homogeneous.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.

Manufacturer Narrative

Context: the customer did complaint about his new previ color v2 reference (b)(4) and serial number (b)(6).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.The customer reported random staining issues : gram negative which are staining blue instead of pink.Gram positive which are staining pink instead of violet.Heterogenous staining (mix of violet and pink bacilli for gram negative strains).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.Immediate action done by biomerieux local customer service: the field application specialist performed troubleshooting with customer.Impact & workaround: there were no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.An analysis has been done regarding the complaints recorded for a staining issue.Refer to the file attached ¿case (b)(4) - complaint analysis¿ for details.Probability as per safety risk management procedure 001622 rev 08.C : improbable.The final risk is "irrelevant" following procedure 001622 rev 08.C investigation: 1.Complaint trend analysis and device history record referring to (b)(4) - technical complaint trend analysis using the cstat application, there is no out-of-control alert, or a non-confirmed out-of-control alert in cstat for now.We checked the period from july 2023 to september 2023 for the error code staining issue - ca38.2.Investigation: trouble shooting with customer allows to find that the staining issue was probably due to microscope slides that were too greasy.Based on this finding, no further investigation on this instrument serial number (b)(6) was required.3.Root cause analysis: microscope slides quality issue.4.Corrective or preventive actions: no capa number is needed.There is no capa, no non conformity on previ color linked with customer 's complaint.

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.Issue description: a customer in france notified biomérieux of obtaining incorrect gram stains, both positive when expected is negative and negative when expected is positive associated with previ color gram instrument v2 (ref.(b)(4), serial (b)(6)).The customer noted that this issue has been ongoing since obtaining the instrument in october of 2022 and that the slides are not homogeneous.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.

• Brand Name: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Type of Device: PREVI COLOR GRAM INSTRUMENT V2 - 414292
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16564656
• MDR Text Key: 311587502
• Report Number: 8020790-2023-00017
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 03573026415310
• UDI-Public: 03573026415310
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414292
• Device Catalogue Number: 414292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• 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