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

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

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

(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 Description

Report 2 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 positive.Results were as follows: 1st run (ct positive), 2nd run (ct negative), and 3rd run (ct positive).There was no report of patient impact.

• Brand Name: BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX ASSAY GRAY AMP REAGENT PACK
• Type of Device: 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: 19133366
• MDR Text Key: 340484186
• Report Number: 1119779-2024-00303
• Device Sequence Number: 1
• Product Code: MKZ
• UDI-Device Identifier: 00382904429591
• UDI-Public: (01)00382904429591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442959
• Device Lot Number: 3313789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• 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