MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® LYSIS BUFFER

Catalog Number 200292

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Type  malfunction  

Event Description

A customer in france notified biomérieux of observing a potential contamination with aspergillus fumigatus when using nucl.Lysis buf 2ml 48t (ref.(b)(4), lot number 22033005, expiry date 24-feb-2024).The customer stated that after swabbing, he found no aspergillus dna in the emag or in the room.He suspects the contamination comes from lysis buffer tube lot 22033005.The sample is a respiratory sample.Extraction was performed on emag and amplification with homebrew pcr on cfx instrument.Three runs were carried out: run on (b)(6) 2023: test performed with hemolysis tubes and water.Extractions on right and left section of emag.Iqc is conform (ct= 29.98 and 35.43).No positive results on the 14 samples.Run on (b)(6) 2023 : test performed with empty lysis tubes from nucl.Lysis buf 2ml 48t batch 22033005 (no sample or water added).Extractions on right and left section of emag.Iqc is conform (ct= 30.44 and 36.73).G04 well: 42.61 ct (positive signal).Run on (b)(6) 2023 : test performed with empty lysis tubes from nucl.Lysis buf 2ml 48t batch 220330050 (no sample or water added).Extractions on right and left section of emag.Iqc is conform (ct= 32.07).A05 well: 38.36 ct (positive signal).Following these results, the customer performed troubleshooting tests: for the run performed on (b)(6) 2023: with only ¿baseline subtracted curve fit¿ option selected : one replicate out of 16 gave a late positive signal at 43.85 ct (well g03).There is a flat curve (high background).With ¿baseline subtracted curve fit & apply fluorescence drift correction¿ option selected : all replicates gave a negative signal.It is suspected that this run was made without lysis buffer.Therefore, the very low positive signal observed for this test is only an unusual fluorescence background in pcr and was suppressed by applying the fluorescence drift correction option as seen here.For the run performed on (b)(6) 2023: with only ¿baseline subtracted curve fit¿ option selected : one replicate out of 16 gave a late positive signal at 42.61ct.There is a flat curve (high background).With ¿baseline subtracted curve fit & apply fluorescence drift correction¿ option selected : all replicates gave a negative signal.For the run performed on (b)(6) 2023: with only ¿baseline subtracted curve fit¿ option selected : one replicate out of 16 gave positive signal at 38.36 ct (well a05).There is a real amplification curve.With ¿baseline subtracted curve fit & apply fluorescence drift correction¿ option selected : one replicate out of 16 gave a positive signal at 38.36 ct (well a05).There is a real amplification curve.After these troubleshooting test results, the customer confirms that the only real positive signal is the one from the last run ((b)(6) 2023).Regarding the potential impact of the contamination on patient results, at the time of this assessment, the customer has not provided clear information about any potential false results.No delayed results occurred since the customer sent their samples to another laboratory for testing.The customer reported a similar issue on another lot 22032403 managed in complaint (b)(4).A biomérieux internal investigation was initiated.

Manufacturer Narrative

An internal investigation was opened following a notification from a customer in france regarding contamination with aspergillus fumigatus of nucl.Lysis buf 2ml 48t (ref.200292, lot number 22033005, expiry date 24-feb-2024).Investigation results 1.Batch history record the batch history record did not highlight any issue during manufacturing of lot 22033005 of nucl.Lysis buf 2ml 48t (ref.200292).2.Complaint analysis no other complaint was recorded for lot 22033005 of nucl.Lysis buf 2ml 48t (ref.200292) for contamination issue.3.Tests performed no specific pcr against asp.Fumigatus was carried out in biomerieux facilities as this pcr is not tavailable internally and since there is a backorder for this reference (competitor provider).3.1.Detection and identification of bacterial dna 16s tests for detection and identification of bacterial dna were carried out lot 22033005 of lysis buffer: no abnormal level of signal was observed.Therefore no 16s contamination was detected for the tested lot.3.2.Decontamination of emag at customer site the customer performed emag system decontamination on site on 21-sep-2023.A contamination test was carried out on 26-sep-2023 and showed no contamination.4.Conclusion since 16s testing revealed no bacterial dna in the lysis buffer, and given that decontamination of the emag system at customer site resolved the issue, biomérieux suspects that the root cause of the observed false positive results was an emag system contamination, not related to the lysis buffer lot 22033005.For these reasons, there is no reconsideration of the performance of lot 22033005 of nucl.Lysis buf 2ml 48t (ref.200292).

• Brand Name: NUCLISENS® LYSIS BUFFER
• Type of Device: NUCLISENS® LYSIS BUFFER
• Manufacturer (Section D): BIOMERIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer (Section G): BIOMÉRIEUX SA; 5 rue des berges; grenoble 38024 ; FR 38024
• Manufacturer Contact: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17574263
• MDR Text Key: 322371436
• Report Number: 3008249922-2023-00003
• Device Sequence Number: 1
• Product Code: PPM
• 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: 10/27/2023

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: 02/28/2024
• Device Catalogue Number: 200292
• Device Lot Number: 22033005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1