MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MOLECULAR SWAB COLLECTION KIT; UNKNOWN

Model Number 443904

Device Problem False Positive Result (1227)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that while using bd molecular swab collection kit there was a high positivity rate on the ctgctv2 assay for the ct target.No patient impact was reported.The following information was provided by the initial reporter: customer reports ctgctv2 assay "high positivity rate for ct target", according to their providers.

Manufacturer Narrative

Product 443904 (bd ctgctv2 for bd max¿ system (us)) is associated with product 443925 bd molecular swab collection kit, 510(k) number k182692.Information from this associated product was used for the following fields: describe event or problem.Medical device brand name.Common device name.Medical device type.Pma/510(k)#.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: review of the manufacturing records of the bd max ctgctv2 indicated that lot 2011762 was manufactured according to specifications and met performance requirements.More details about the complaint were requested but no information was provided.The investigation was thus limited.The database included 136 runs tested with various assays (gbs, vaginal panel and ctgctv2), over 3 months (b)(6) 2022.Overall, 813 samples were tested with the bd max¿ ctgctv2 assay, all using kit lot 2011762.Database analysis revealed that when excluding the positive control samples, the positivity rate for the ct target decreased in time, from (b)(4) in july to (b)(4) in august and (b)(4) in september.Without more details on the issue regarding the period or number of samples involved, all the patient samples that gave a ct positive result in the month of september (runs 63 to 135) were analyzed and manual pcr curves adjudication were performed.Among 24 samples that gave a ct positive result, 22 showed a true amplification curve, with mostly early results, aside from 2 of them which gave a low and late but true amplification of the ct target (run 98 b7 and run 90 a7).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.Other targets were also verified and showed no issue.For the 2 remaining samples (run 118 a10 and run 115 a4), a step dislocation in the raw pcr signal in all channels was observed, resulting in a positive result for the ct target.It is unlikely these positive results are true amplifications.Unfortunately, no root cause could be identified.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal or atypical curve geometry is a conservative assessment of the data.On september 27th, customer performed environmental monitoring using a single sample (swab of multiple zones) and it gave a negative result.Overall, no reagent issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max ctgctv2 lot 2011762.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

Event Description

It was reported that while using bd molecular swab collection kit there was a high positivity rate on the ctgctv2 assay for the ct target.No patient impact was reported.The following information was provided by the initial reporter: customer reports ctgctv2 assay "high positivity rate for ct target", according to their providers.

• Brand Name: BD MOLECULAR SWAB COLLECTION KIT
• 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: 15540386
• MDR Text Key: 303043272
• Report Number: 3007420875-2022-00061
• 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: 12/21/2022

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: 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: 09/29/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 12/27/2022
• 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