MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX40 INSTRUMENT; SYSTEM, BLOOD CULTURING

Model Number	442296
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd bactec¿ fx40 instrument false negatives are being reported even with gram stain with a huge amount of gram negative bacili.The following information was provided by the initial reporter: the client reports that after the end of the 5-day protocol incubation, when the bottle comes out with a negative result, when performing the gram test, bgn are visualized.False negative, even with the gram stain with a huge amount of gram negative bacilli.
Event or Problem Description
It was reported that bd bactec¿ fx40 instrument false negatives are being reported even with gram stain with a huge amount of gram negative bacili.The following information was provided by the initial reporter: the client reports that after the end of the 5-day protocol incubation, when the bottle comes out with a negative result, when performing the gram test, bgn are visualized.False negative, even with the gram stain with a huge amount of gram negative bacilli.
Additional Manufacturer Narrative
A results failure was reported on a bactec fx40 instrument (p/n 442296, s/n (b)(6)).The customer reported that after the end of the 5-day protocol incubation the bottle comes out with a negative result, but the gram test was positive.A bd field service engineer (fse) was dispatched to investigate.Log files were reviewed, and no instrument or abnormalities were witnessed, preventive maintenance was carried out in the instrument with no failures or issues present, the sample was the only one reported to be affected during the run, leading bd to believe this may be an issue with the sample integrity, based on the data the root cause is unable to be determine.This is an unconfirmed failure of a bd product.Physical samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.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 from manufacturing due to service repairs/pms.Service history review for this instrument was completed and revealed one previous complaint related to results.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• Common Device Name: SYSTEM, BLOOD CULTURING
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16948415
• Report Number: 1119779-2023-00560
• Device Sequence Number: 6554896
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K915796
• 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): 08/24/2023

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 Model Number: 442296
• Device Catalogue Number: 442296
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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