MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD COR GX INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Catalog Number	443990
Medical Device Problem Codes	False Negative Result (1225); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the bd cor gx instrument, "results don't match" on a clinical sample.Hpv-16 was detected with other targets "indeterminate" and "undetectable." a confirmation test was then performed and hpv-51 was also detected.There was no report of patient impact.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that during use of the bd cor gx instrument, "results don't match" on a clinical sample.Hpv-16 was detected with other targets "indeterminate" and "undetectable." a confirmation test was then performed and hpv-51 was also detected.There was no report of patient impact.

• Brand Name: BD COR GX INSTRUMENT
• Common Device Name: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22815366
• Report Number: 1119779-2025-03408
• Device Sequence Number: 5714972
• Product Code: MAQ
• UDI-Device Identifier: 00382904439903
• UDI-Public: (01)00382904439903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Catalogue Number: 443990
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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