MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR¿ GX INSTRUMENT; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

Catalog Number	443990
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cor gx instrument, there was a false positive result for hpv for one patient.Repeat testing was performed on the cor gx and indicated that the result was negative.The same sample also underwent confirmatory testing on viper lt instrument and the result was negative.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D4: medical device expiration date: unknown.H4: 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 or Problem Description
It was reported while using bd cor gx instrument, there was a false positive result for hpv for one patient.Repeat testing was performed on the cor gx and indicated that the result was negative.The same sample also underwent confirmatory testing on viper lt instrument and the result was negative.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: this complaint alleges the negative control failed leading to false positive results on the bd cor gx.The results from the run should have been suppressed rather than reported due to the control failure.This issue was escalated, and it was determined that an incorrect cutoff was applied to the negative control, which caused the neg control to show as fail.A software change request was created to correct the logic to appropriately set the negative control ct cutoff values which incorrectly resulted in this control failure.This complaint is confirmed, and the root cause is a software bug.Physical samples were not received by quality for investigation however, log files were received and reviewed.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release for manufacturing due to service repairs/pms.Service history review revealed there were no previous complaints for this issue.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.

• Brand Name: BD COR¿ GX INSTRUMENT
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• 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: 22236663
• Report Number: 1119779-2025-00596
• Device Sequence Number: 9041625
• Product Code: MAQ
• UDI-Device Identifier: 00382904439903
• UDI-Public: (01)00382904439903
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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