MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK; DNA REAGENTS, NEISSERIA

Catalog Number	442842
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd probetec¿ neisseria gonorrhoeae (gc) qx assay gray amp reagent pack patient sample tested positive for gc however when retested patient was gc negative.The following information was provided by the initial reporter: customer reports one patient sample with a discrepant gc result while using cat 442842 lot 2348937.Per customer, a ct/gc specimen was tested on (b)(6) 2023 and it was positive for gc.Provided called customer on (b)(6) 2023 asking for specimen to be repeated as patient should not be positive.Patient had testing done at another facility and gc result was negative.Customer could not provide the name of the other facility or the instrumentation/methodology used.Last ct/gc em were performed on (b)(6) 2023.Customer alternates every other month with hpv.Ct/gc only performed once a week.Customer will repeat the specimen on (b)(6) 2023 with the rest of the new specimens and em.Per customer, the specimen had a very low value in the report.Follow up email sent to customer requesting result print out.If yes, detailed erroneous results (include # of errors and type): gc result was reported as positive.Patient questioned the results and a new test was performed at a different facility and the result was negative.Provided contacted customer to repeat testing from original sample.Patient has not been treated.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd probetec¿ neisseria gonorrhoeae (gc) qx assay gray amp reagent pack patient sample tested positive for gc however when retested patient was gc negative.The following information was provided by the initial reporter: customer reports one patient sample with a discrepant gc result while using cat 442842 lot 2348937.Per customer, a ct/gc specimen was tested on (b)(6) 2023 and it was positive for gc.Provided called customer on (b)(6) 2023 asking for specimen to be repeated as patient should not be positive.Patient had testing done at another facility and gc result was negative.Customer could not provide the name of the other facility or the instrumentation/methodology used.Last ct/gc em were performed on (b)(6) 2023.Customer alternates every other month with hpv.Ct/gc only performed once a week.Customer will repeat the specimen on (b)(6) 2023 with the rest of the new specimens and em.Per customer, the specimen had a very low value in the report.Follow up email sent to customer requesting result print out.If yes¿detailed erroneous results (include # of errors and type): gc result was reported as positive.Patient questioned the results and a new test was performed at a different facility and the result was negative.Provided contacted customer to repeat testing from original sample.Patient has not been treated.
Additional Manufacturer Narrative
H.6.Investigation summary: bd integrated diagnostic systems initiated an investigation into discrepant results on the ctqx/gcqx assay on the bd viper lt system (catalog # 442842, batch # 2348937).Bd investigation required review of the batch history records, functional analysis on customers reported reagent batches and complaint trending review.The batch history records were reviewed and no discrepancies were noted.Functional analysis on the customers reported reagent batches were performed and the results met acceptance criteria.We were unable to confirm the customers complaints.There are no current trends associated with discrepant results on the ctqx/gcqx assay on the bd viper lt system.Bd apologizes for any inconvenience.If there are any questions or concerned, please so not hesitate to contact bd technical services.

• Brand Name: BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK
• Common Device Name: DNA REAGENTS, NEISSERIA
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17663467
• Report Number: 1119779-2023-00964
• Device Sequence Number: 12343329
• Product Code: LSL
• UDI-Device Identifier: 00382904428426
• UDI-Public: 00382904428426
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 442842
• Device Lot Number: 2348937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown