MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX EXK DNA-3CLINICAL SAMPLE CONCENTRATOR

Model Number	442821
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd max¿ exk¿ dna-3 false positive results contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: customer reports that replacement received under case (b)(4) is also positive for e.Faecalis.
Event or Problem Description
It was reported that while using bd max¿ exk¿ dna-3 false positive results contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer reports that replacement received under case (b)(4).Is also positive for e.Faecalis ".
Additional Manufacturer Narrative
H.6.Investigation: the complaint investigation for negative control failures and false positive result when using bd max exk dna-3 kit (ref (b)(4) from lot 1103395 was performed by the review of manufacturing records, analysis of customer data and verification of complaints history.Review of the manufacturing records of the bd max exk dna-3 kit indicated that the lot was manufactured according to specifications and met performance requirements.Databases from the customer¿s two instruments were provided and analyzed and it revealed that several bd max¿ exk¿ dna-3 kit lots were used to perform the wp-2 panel since january 2020.The e.Faecalis positivity rate before march 2021 was near 35% but has increased to near 100% since.However, it must be noted that a small number of samples have been tested since march 2021.Only 3 samples were tested with the bd max¿ exk¿ dna-3 kit lot 1103395 and were all e.Faecalis positive.Manual pcr curve adjudication revealed that these e.Faecalis curves had a similar shape compared to many other samples in randomly selected runs, with late ct values.The curves are late but show a strong amplification and all crossed the ct threshold.Also, the shape was similar, regardless of the type of samples tested.Similar curves were also observed with older kit lots used in early 2020.Moreover, customer initially performed an internal investigation, during which wp-2 tests were also performed with the bd max¿ exk¿ dna-1 assay and several samples presented the same increase of fluorescent signal in the fam channel.The fact that this amplification is present in many samples, and presented a similar aspect every time, suggests that the amplification observed is not specific.Manufacturing of bd max¿ assays is conducted in cleanrooms to prevent contamination of the kit's components during the manufacturing process.As such, it is very unlikely that the positive results obtained by the customer is coming from a live organism contamination during production.Moreover, e.Faecalis is not used for any molecular tests or microbiological test as part of its manufacturing process or quality control testing.A raw material analysis was performed on several bd max¿ exk¿ dna-3 and dna-1 kit lots and no link with any raw material lot or process was identified which could have explained the results obtained by the customer.Overall, considering that multiple kit lots, as well as multiple types of bd max¿ exk¿ dna assays kits and types of samples processed all showed this increase in the fam channel (e.Faecalis target), this suggests amplification is not specific to the samples nor related to specific lots of reagents.There is no indication of an increase in complaints for negative controls failures or false positive for the bd max exk dna-3 usa kit lot 1103395.Based on the available information, bd was unable to determine the root cause of the customer issue.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.See h.10.

• Brand Name: BD MAX EXK DNA-3CLINICAL SAMPLE CONCENTRATOR
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 12019110
• Report Number: 3007420875-2021-00019
• Device Sequence Number: 14643904
• Product Code: JJH
• UDI-Device Identifier: 00382904428211
• UDI-Public: 00382904428211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Other
• Device Expiration Date: 09/17/2022
• Device Model Number: 442821
• Device Catalogue Number: 442821
• Device Lot Number: 1103395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1