MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ CT/GC/TV; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Catalog Number 442970

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd max¿ ct/gc/tv, that there were discrepant tv results from the same patient.This is a report for a single occurrence.There were no false results reported out to the patient or the clinician.The following information was provided by the initial reporter: customer reports that they performed both the ct/gc/tv panel and vaginal panel for the same patients and the tv results were different between the two assays.Per customer, they had at least 6 instances where patient samples were collected for both vaginal panel and ct/gc/tv and upon testing, the tv result was positive for the vaginal panel but negative for the ct/gc/tv assay.All ct/gc/tv tests were done using ct2310.The vaginal panel tests were done using ct1321.Discussed the possibility of lod and specimen collection affecting results.Customer will collected specimen information like run number and position.

Manufacturer Narrative

Correction: new information has been received regarding mfr.Report # 1119779-2022-01065 indicating the discrepant tv was an instrument normalization issue, not a reagent issue making it not reportable.

Event Description

It was reported that while using bd max¿ ct/gc/tv, that there were discrepant tv results from the same patient.This is a report for a single occurrence.There were no false results reported out to the patient or the clinician.The following information was provided by the initial reporter: customer reports that they performed both the ct/gc/tv panel and vaginal panel for the same patients and the tv results were different between the two assays.Per customer, they had at least 6 instances where patient samples were collected for both vaginal panel and ct/gc/tv and upon testing, the tv result was positive for the vaginal panel but negative for the ct/gc/tv assay.All ct/gc/tv tests were done using ct2310.The vaginal panel tests were done using ct1321.Discussed the possibility of lod and specimen collection affecting results.Customer will collected specimen information like run number and position.

• Brand Name: BD MAX¿ CT/GC/TV
• Type of Device: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15166796
• MDR Text Key: 305048643
• Report Number: 1119779-2022-01065
• Device Sequence Number: 1
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 382904429706
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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 Catalogue Number: 442970
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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