MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK; DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Catalog Number	442959
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional phone # (b)(6).H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 3 of 3 it was reported when using the bd probetec¿ chlamydia trachomatis (ct) qx assay gray amp reagent pack, discrepant result reproducibility occurred.In between the 2nd and 3rd runs, the user found ferric oxide on top of the extraction rack and thoroughly cleaned to remove any possible contamination.The user repeated the affected specimen again after cleaning and the final result matched the initial result of ct negative.Results were as follows: 1st run (ct negative), 2nd run (ct positive), and 3rd run (ct negative).There was no report of patient impact.
Additional Manufacturer Narrative
H.6 investigation summary bd integrated diagnostic systems initiated an investigation into potential contamination resulting in discrepant patient results for the ct/gc assay on the bd viper lt system (catalog # 442959, batch # 3355797).Bd investigation required review of the batch history records and complaint trending review.The batch history records were reviewed and intitial release testing for the customers reported reagent batch met acceptance criteria.There are no current complaint trends associated with discrepant patient results for the ct/gc assay.Bd was unable to confirm or duplicate the customers report.After evaluation of the customer complaint report stating ferric ozide was present on the extraction tray, bd recommends rigorous cleaning and environmental monitoring to prevent any further potential contamination of patient results.Bd quality will continue to monitor for trends associated with discrepant patient results for the ct/gc assay on the bd viper lt system.
Event or Problem Description
Report 3 of 3 it was reported when using the bd probetec¿ chlamydia trachomatis (ct) qx assay gray amp reagent pack, discrepant result reproducibility occurred.In between the 2nd and 3rd runs, the user found ferric oxide on top of the extraction rack and thoroughly cleaned to remove any possible contamination.The user repeated the affected specimen again after cleaning and the final result matched the initial result of ct negative.Results were as follows: 1st run (ct negative), 2nd run (ct positive), and 3rd run (ct negative).There was no report of patient impact.

• Brand Name: BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK
• Common Device Name: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19133369
• Report Number: 1119779-2024-00302
• Device Sequence Number: 4722129
• Product Code: MKZ
• UDI-Device Identifier: 00382904429591
• UDI-Public: (01)00382904429591
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 05/31/2025
• Device Catalogue Number: 442959
• Device Lot Number: 3313789
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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