MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ CT/GC/TV; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Model Number 442970

Device Problem False Positive Result (1227)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd max¿ ct/gc/tv assay on the bd max¿ instrument a false positive result was produced.No confirmatory testing was used.The test was repeated on the bd max.There was no report of adverse patient impact.The following information was provided by the initial reporter: "it was reported by the customer that there is a false positive.Customer is reporting discrepant results when using 442970, lot #2025616.Customer states the results was positive for gonorrhea initially, then repeated twice - the result was negative with each repeat.".

Manufacturer Narrative

H.6: customer complained about discrepant results.A sample initially gave a positive n.Gonorrhoeae (gc) result with the bd max¿ ctgctv assay, but when retested twice, it tested negative.No other complaint was received on the bd max¿ ctgctv kit lot 2025616.In the last twelve months, 7 other complaints were received about false positive or discrepant results with the bd max¿ ctgctv assay.Among them, 4 were for the gc target.Most probable root causes identified were contamination of the samples and sample at the limit of detection of the assay.Based on the complaint review, no reagents issue was identified for this product.No anomaly was observed, in bhr review of bd max¿ ctgctv kit lot 2025616 which could have a link with the customer issue.Also, the kit met the release specifications and qc results were within the trends.The retain material did not need to be tested since it would not provide more information than what is available from the final qc test.A gross product contamination would have been detected by the final qc test, which is not the case.No sample was received for the investigation.Runs 1968, 1971 and 1972 were provided and manual pcr curve adjudication was performed.The analysis showed true but late amplification of the gc target in run 1968 in position a1, without anomaly.No amplification of the gc target was observed in run 1971 position a11 and run 1972 position a12.Low positive samples can occur due to low bacterial load in the specimen being at or near the limit of detection of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Based on the data and information provided, a specimen at or near the assay limit of detection (lod), or environmental or cross contamination, are the most likely causes to explain the customer¿s positive result in run 1968.However, bd is unable to confirm the exact cause of the issue.Nonetheless, no reagents issue is suspected.

Event Description

It was reported when using the bd max¿ ct/gc/tv assay on the bd max¿ instrument a false positive result was produced.No confirmatory testing was used.The test was repeated on the bd max.There was no report of adverse patient impact.The following information was provided by the initial reporter: "it was reported by the customer that there is a false positive.Customer is reporting discrepant results when using 442970, lot #2025616.Customer states the results was positive for gonorrhea initially, then repeated twice - the result was negative with each repeat.".

• Brand Name: BD MAX¿ CT/GC/TV
• Type of Device: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14681712
• MDR Text Key: 294060208
• Report Number: 3007420875-2022-00031
• Device Sequence Number: 1
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 00382904429706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

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: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 2025616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1