MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD CTGCTV2 FOR BD MAX¿ SYSTEM (US); UNKNOWN

Model Number 443904

Device Problem False Positive Result (1227)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported that while using bd ctgctv2 for bd max¿ system (us) there was discrepant results with one patient sample.The customer reported positive results for gc on that patient sample and the patient then went to another hospital to get tested using hologic platform (not bd) and the repeat was negative.Medications or follow up are unknown.No patient impact was reported.The following information was provided by the initial reporter: customer reports max ctgctv2 assay discrepant results on one patient sample.Hazard, injury or erroneous results details - discrepant results with another platform (not bd).Customer reported positive results for gc on (b)(6) 2022; vaginal sample; female patient.Patient went to another hospital to get a new sample collected.The repeat test was processed on hologic platform as negative.Patient impact: medications or follow up unknown.

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: two other complaints were received on the bd max¿ ctgctv2 kit lot 2011762.The other one was for an unrelated issue.In the last twelve months, one other complaint was received about false positive result (described above) and none about discrepant results with the bd max¿ ctgctv2 assay.Based on the complaint review, no reagents issue was identified.No anomaly was observed, in bhr review of bd max¿ ctgctv2 kit lot 2011762 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.Two runs were received for the investigation and were analyzed with the bancs algorithm simulation software.Manual pcr curve adjudication was performed and showed true but late amplification of the gc target in run 120 position a12, without anomaly.Overall, 12 samples were tested with the bd max¿ ctgctv2 assay in run 120 on (b)(6) and no other sample gave a positive result.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.On (b)(6), customer performed environmental monitoring (using one swab of multiple zones; run 134) and it gave a negative result.Moreover, despite a negative environmental monitoring, environmental or cross contamination of the sample, could also explain the issue.Overall, although bd is unable to confirm the exact cause of the issue, no reagents issue is suspected.

Event Description

It was reported that while using bd ctgctv2 for bd max¿ system (us) there was discrepant results with one patient sample.The customer reported positive results for gc on that patient sample and the patient then went to another hospital to get tested using hologic platform (not bd) and the repeat was negative.Medications or follow up are unknown.No patient impact was reported.The following information was provided by the initial reporter: customer reports max ctgctv2 assay discrepant results on one patient sample.Hazard, injury or erroneous results details - discrepant results with another platform (not bd).Customer reported positive results for gc on 9/23/2022; vaginal sample; female patient.Patient went to another hospital to get a new sample collected.The repeat test was processed on hologic platform as negative.Patient impact: medications or follow up unknown.

• Brand Name: BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)
• Type of Device: UNKNOWN
• 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: 15577673
• MDR Text Key: 307019134
• Report Number: 3007420875-2022-00066
• Device Sequence Number: 1
• Product Code: OUY
• UDI-Device Identifier: 00382904439040
• UDI-Public: 00382904439040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182692
• 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: 11/29/2022

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: 07/29/2023
• Device Model Number: 443904
• Device Catalogue Number: 443904
• Device Lot Number: 2011762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1