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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX EXK DNA-1; CLINICAL SAMPLE CONCENTRATOR
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GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX EXK DNA-1; CLINICAL SAMPLE CONCENTRATOR Back to Search Results
Model Number 442817
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using 5 bd max¿ exk¿ dna-1 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: " max 442817_1089873 e.Feacalis contamination; ".
 
Manufacturer Narrative
H6: investigation summary: the complaint investigation for contamination when using bd max exk dna-1 kit (ref #(b)(4)) from lot 1089873 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-1 kit lot indicated that the lot was manufactured according to specifications and met performance requirements.Material was received from the customer (2 kits) however the returned material was not tested.Testing the returned material for this kit would not provide more information on the cause of the customer issue.The customer is using a kit from another provider (biogx), which contains the primers and probes specific to the customer¿s targets.The customer alleges that the bd max¿ exk¿ dna-1 kits are the source of the e.Faecalis positive in their tests.The database of instrument ct2222 was analyzed and contains 190 samples tested with a biogx test / bd max exk dna-1 combination which is used to detect the e.Faecalis target in urine sample.A total of two lots were used, lot 0282375 and lot 1089873 included in the present complaint.Lot 0282375 obtained a positivity rate for e.Faecalis of (b)(4) and 1089873 lot got (b)(4).Manual pcr curve adjudication was conducted and revealed that almost every sample tested with the bd max¿ exk¿ dna-1 lot 1089873 was positive for e.Faecalis.Similar curves were also observed in validation runs (runs 46 and 47), performed with the bd max¿ exk¿ dna-3 assay, suggesting that the issue is not recent and has been there since the beginning of the use of this test.In general, these increases are found in all types of samples (qc, blank and patient samples).The fact that this amplification is present in many samples, and presents 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.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 contamination for the bd max exk dna-1 kit lot 1089873.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 quality will continue to monitor for trends.H3 other text : see h10.
 
Event Description
It was reported that while using 5 bd max¿ exk¿ dna-1 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: "max 442817_1089873 e.Feacalis contamination;".
 
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Brand Name
BD MAX EXK DNA-1
Type of Device
CLINICAL SAMPLE CONCENTRATOR
Manufacturer (Section D)
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
2555 blv. du parc techn
quebec
MDR Report Key12207491
MDR Text Key263487254
Report Number3007420875-2021-00040
Device Sequence Number1
Product Code JJH
UDI-Device Identifier00382904428174
UDI-Public00382904428174
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/01/2022
Device Model Number442817
Device Catalogue Number442817
Device Lot Number1089873
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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