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

Catalog Number 443990

Device Problem False Negative Result (1225)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It was reported that after usage of bd cor gx instrument they received erroneous results with a false negative.The following was reported by the initial reporter: 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).Customer has doubt on patient result.

Manufacturer Narrative

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

It was reported that after usage of bd cor gx instrument they received erroneous results with a false negative.The following was reported by the initial reporter: 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) customer has doubt on patient result.

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd cor gx instrument (catalog number 443990 and serial number (b)(6)) had a 'false negative".Customer has experienced a false negative result from a consumable complaint and had doubt about the results on the 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 instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or a failure at install.Device was installed on (b)(6) 2021, and since then other service activities have occurred, such as preventative maintenance and repair, which have changed the configuration of the 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.Bd quality will continue to monitor trends associated with this failure mode.H3 other text : see h.10.

• Brand Name: BD COR GX INSTRUMENT
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17941631
• MDR Text Key: 325754797
• Report Number: 1119779-2023-01133
• Device Sequence Number: 1
• Product Code: OOI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1