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

Model Number 442970

Device Problem False Positive Result (1227)

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

Event Date 03/22/2021

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 while using bd max¿ ct/gc/tv a false positive for gc was obtained.Sample was recollected and retested and the result was negative.There was no report of additional patient impact.The following information was provided by the initial reporter: max ctgctv discrepant result; reported by mas on instrument initial gc positive result disputed and recollect sample result was gc negative position a8 (endocervical patient sample) -initial result ct neg, gc pos, tv neg; customer states sample repeated and all results matched; positive gc result reported and result disputed; recollection of endocervical sample from same patient and tested on ct2112 with ctgctv (lot k58028237020211109), run 22 (4/1/2021), position b3 ¿ recollect sample results all negative for ct, gc, and tv;.

Manufacturer Narrative

H.6.Investigation: the complaint investigation for discrepant results when using the bd max ct/gc/tv (ref 442970) lot 0350755 was performed by the review of manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max ct/gc/tv indicated that lot 0350755 was manufactured according to specifications and met performance requirements.Customer complained about one gc positive result that was positive on the initial test (run 16) and upon retest (data not provided).The gc positive result was considered suspicious by the customer and a new sample was recollected for a retest.Negative result was obtained with the new sample (run 22).Customer provided two run files (runs 16 and 22) from instrument ct2112 for investigation.Manual pcr curve adjudication was performed on the discrepant samples.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is an extremely conservative assessment of the data.Analysis of the pcr curves shows true but low amplification without anomaly indicative of true positive results.Low positive samples can occur due to viral titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Bd was unable to confirm the exact cause of the customer¿s discrepant results.Overall, no product issue is suspected.There is no indication of an increase in complaints for discrepant results for the bd max ct/gc/tv lot 0350755.The root cause was not identified but positives samples at the limit of detection of the assay and/or contamination by customers are suspected.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

Event Description

It was reported while using bd max¿ ct/gc/tv a false positive for gc was obtained.Sample was recollected and retested and the result was negative.There was no report of additional patient impact.The following information was provided by the initial reporter: max ct, gc, tv discrepant result; reported by mas on instrument initial gc positive result disputed and recollect sample result was gc negative position a8 (endocervical patient sample) -initial result ct neg, gc pos, tv neg; customer states sample repeated and all results matched; positive gc result reported and result disputed; recollection of endocervical sample from same patient and tested on ct2112 with ct, gc, tv (lot k58028237020211109).Run 22 ((b)(6) 2021), position b3 ¿ recollect sample results all negative for ct, gc, and tv.

• Brand Name: BD MAX CT/GC/TV
• Type of Device: TRICHOMONAS VAGINALIS NUCLEIC ACID AMP .TEST SYS
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 11755580
• MDR Text Key: 268260210
• Report Number: 3007420875-2021-00014
• Device Sequence Number: 1
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 00382904429706
• Combination Product (y/n): N
• PMA/PMN Number: K151589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: 12/21/2021
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 0350755
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1