MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD COR GX INSTRUMENT

Catalog Number	443990
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd cor gx instrument has doubt on result.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details the customer always looks through the c-files after runs and has doubt on result.In the c-files ct value for cy5, hpv p3 = 27,58 / final result is negative.For customer a ct value of 27,58 should not provide a negative result as conclusion the sample has been retest on the 2nd bd cor ct value = 27,51 and conclusion is negative (the sample is positive for hpv45 and hpv p2, on both system).
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 cor gx instrument has doubt on result.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details the customer always looks through the c-files after runs and has doubt on result.In the c-files ct value for cy5, hpv p3 = 27,58 / final result is negative.For customer a ct value of 27,58 should not provide a negative result as conclusion.The sample has been retest on the 2nd bd cor ct value = 27,51 and conclusion is negative.(the sample is positive for hpv45 and hpv p2, on both system).
Additional Manufacturer Narrative
H.6.Investigation summary: the complaint alleges the bd cor gx instrument (catalog # 443990 / sn: (b)(6)) had a 'false negative".Customer experienced a false negative result from a consumable complaint and had doubt about results on instrument.Application specialist came onsite and presented their findings to the customer.No instrument issues were noted during the visit.Review of device history record for (b)(6) is not required because this complaint does not allege an early life failure or a failure at install.Device installed on (b)(6) 2019, and since then, other service activities have occurred, such as pm or repair, which changed configuration of instrument since release from manufacturing.Service history review was performed for the instrument (b)(6) and no additional work order was observed for the complaint failure mode reported.Samples were not expected to be returned for investigation, therefore returned sample analysis is not performed.Root cause cannot be determined with the information provided.Complaint was unconfirmed by application specialist.Review of risk management files confirms there are no new, modified, or additional risks associated with this failure mode.

• Brand Name: BD COR GX INSTRUMENT
• Common Device Name: NA
• 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: 17940973
• Report Number: 1119779-2023-01128
• Device Sequence Number: 17751235
• Product Code: QEP
• UDI-Device Identifier: 00382904439903
• UDI-Public: (01)00382904439903
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: NA
• 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): 01/18/2024

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 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: 09/20/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• 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