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 10/03/2022

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ ct/gc/tv the customer got a false positives for chlamydia.Sample was recollected and rerun and came out negative.No patient impact was reported.The following information was provided by the initial reporter: customer claims false pos for chalmydia for 2 patient samples; 1-st false pos obtained on (b)(6) 2022, run # 2626; 2-nd false pos obtained on (b)(6) 2022, run #2631; both samples were re-collected and re-run, both came out neg; repeats were ordered by the doctor; no erroneous results were reported, no unnecessary patient treatments were administered.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: inv-22-plc-365.The complaint concerns two samples, positive for the chlamydia (ct) target with bd max¿ ct/gc/tv (ref#442970) kit lot 2137538, that gave discrepant negative results upon repeat test performed with re-collected specimens.Complaint history review showed no other complaint received on bd max¿ ct/gc/tv kit lot 2137538.In the last twelve months, five other complaints were received regarding discrepant or false positive results with bd max¿ ct/gc/tv.Various potential root causes were identified such as sample contamination and samples at assay limit of detection (lod).Based on the complaint review, no reagents issue was identified.No anomaly was observed, in bhr review of bd max¿ ct/gc/tv kit lot 2137538 which could have a link with the customer issue.Also, the kit met the release specifications and qc results were within the trends.Retain material was not 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 investigation.The customer is questioning positive results for the chlamydia (ct) target with bd max¿ ct/gc/tv kit lot 2137538, and has identified samples (b)(6) in position b11 (run (b)(6)) and sample (b)(6) in position a3 (run (b)(6)) as suspected discrepant results.According to the complaint text, these two samples repeated negative on the bd max¿ from a recollected specimen (run (b)(6) sample (b)(6) and run (b)(6) sample (b)(6)).Manual pcr curve adjudication of samples (b)(6) (run (b)(6)) and (b)(6) (run (b)(6)) revealed late, but true amplification curve in the fam channel (ct target).Late positive samples can occur due to viral titers 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.Repeat tests sample (b)(6) (run (b)(6)) and sample (b)(6) (run (b)(6)) pcr curves analysis, revealed no amplification curve in the fam channel (ct target) for neither of the samples.Based on the data and information provided, specimens 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 results.However, bd is unable to confirm the exact cause of the issue.Nonetheless, no reagents issue is suspected.

Event Description

It was reported that while using bd max¿ ct/gc/tv the customer got a false positives for chlamydia.Sample was recollected and rerun and came out negative.No patient impact was reported.The following information was provided by the initial reporter: customer claims false pos for chalmydia for 2 patient samples; 1-st false pos obtained on 10/03/2022, run # (b)(6); 2-nd false pos obtained on 10/07/2022, run #( b)(6); both samples were re-collected and re-run, both came out neg; repeats were ordered by the doctor; no erroneous results were reported, no unnecessary patient treatments were administered.

• 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: 15621688
• MDR Text Key: 307115277
• Report Number: 3007420875-2022-00067
• 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: 12/02/2022

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: 05/16/2023
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 2137538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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