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 07/30/2021

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 that while testing with bd max" ct/gc/tv there were 9 false positive results obtained for trichomonas vaginalis.Repeat testing results were negative.There was no report of patient impact.The following information was provided by the initial reporter: customer obtained 9 pos patient results for trichomonas vaginalis on side b, repeated the test again on side b and all of the samples came negative.Customer reported the results from the repeat run.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results when using the bd max ct/gc/tv (ref (b)(4)) lot 1089909 was performed by the review of manufacturing records and verification of complaints history.Review of the manufacturing records of the bd max ct/gc/tv indicated that lot 1089909 was manufactured according to specifications and met performance requirements.Customer complained about 9 patient samples that gave a positive tv target result in one run, with the bd max¿ ctgctv kit lot 1089909, but gave negative tv target results upon repeat, on the same instrument deck.Despite multiple attempts, no data was provided for the investigation.The 9 tv pos patient samples were tested on side b of instrument ct1375.Samples were repeated, on the same deck, and were negative.The customer performed environmental monitoring and all the environmental monitoring sites came out negative.An instrument complaint was also opened at the same time for the same issue.The reader on deck b was replaced.Based on the available information, bd was unable to confirm the exact cause of the customer issue.Overall, no reagent issue is suspected.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).H3 other text : see h10.

Event Description

It was reported that while testing with bd max¿ ct/gc/tv there were 9 false positive results obtained for trichomonas vaginalis.Repeat testing results were negative.There was no report of patient impact.The following information was provided by the initial reporter: customer obtained 9 pos patient results for trichomonas vaginalis on side b, repeated the test - again on side b - and all of the samples came negative.Customer reported the results from the repeat run.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12339873
• MDR Text Key: 267302789
• Report Number: 3007420875-2021-00044
• 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: 10/26/2021

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: 03/01/2022
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 1089909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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