MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® EASYMAG® EXTRACTION BUFFER 3

Catalog Number 280132

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from netherlands notified biomérieux of invalid results when testing with nuclisens® nucl.Extr.Buffer 3(4x1l) (ref.280132, lot #z013ch3eb, expiry date: 28-mar-2023) with patient samples.When the issue occurred, the impacted bottle of z013ch3eb was not new.It was taken out of the fridge.The invalid eluates were frothy and there was also crystalized lysis around the tips.It means that there is guanidinium thiocyanate in the eluates.To be noted, all other bottles of batch z013ch3eb used at customer site gave conform results, and customer qc team approved this batch through entry control.The customer confirm that the issue was solved by replacing eb3 bottle.Due to the organisation of the lab's timetable, a large number of samples had to be repeated, leading to a delay in rendering results.There is no indication or report from the laboratory that the delayed results led to any adverse impact to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer from netherlands that they obtained inhibition issue with invalid result leading to delay result when using nuclisens® nucl.Extr.Buffer 3(4x1l) (ref.(b)(4), lot #z013ch3eb).At the date of investigation, no others complaints were recorded for inhibition issue using nuclisens® nucl.Extr.Buffer 3(4x1l) (ref.(b)(4), lot #z013ch3eb).The issue was observed using both easymag® instruments in this department (easymag00368 and easymag00907) with the same bottle of (b)(6).The bottle of extraction buffer 3 which exhibited the issue, was taken out of the fridge, but was no longer full (half-full) so has been used before.All others bottles of batch z013ch3eb gave conform eluates without inhibition.Moreover, customer qc team approved this batch through entry control.No issue detected.No silica present in the eluate.But eluates were somewhat frothy and there was also crystallized lysis around the tips.This aspect is abnormal and indicates that there is probably guanidinium thiocyanate in these eluate which is a pcr inhibitor.The issue was solved by discarding the impacted bottle of nuclisens extraction buffer 3 and replacing with a new one.(the customer used a new lot (z013ef3eb) as the impacted bottle was the last bottle they had of lot z013ch3eb.) the exact root cause of this chemical contamination by guanidinium thiocyanate remains unknown but was probably due to a punctual handling error or misuse.Therefore, according to the data mentioned above, there is no reconsideration of nuclisens® nucl.Extr.Buffer 3(4x1l) (ref.(b)(4), lot #z013ch3eb) performances.

• Brand Name: NUCLISENS® EASYMAG® EXTRACTION BUFFER 3
• Type of Device: NUCLISENS® EASYMAG® EXTRACTION BUFFER 3
• Manufacturer (Section D): BIOMERIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer (Section G): BIOMERIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16088308
• MDR Text Key: 308548170
• Report Number: 3008249922-2023-00001
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 280132
• Device Lot Number: Z013CH3EB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1