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	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd bactec¿ fx40 instrument false negatives occurred.The following information was provided by the initial reporter: species: canine sample volume: 2.5ml (pediatric vial - peds plus/f culture vials (plastic).It is the volume used in the vast majority of our patients and we have never had this problem.Sample collected on (b)(6) and placed in bactec on (b)(6) (position a9) on (b)(6) the bottle came out of the equipment as a negative sample.When we did the gram stain, it was full of gram negative rods.Plate seeding was performed and, in fact, gram-negative bacteria grew.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details.
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.Initial reporter phone: (b)(6).Initial reporter address: (b)(6).
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 bd bactec¿ fx40 instrument false negatives occurred.The following information was provided by the initial reporter: -species: canine.-sample volume: 2.5ml (pediatric vial - peds plus/f culture vials (plastic).It is the volume used in the vast majority of our patients and we have never had this problem.-sample collected on 7/11 and placed in bactec on 8/11 (position a9).-on 11/14 the bottle came out of the equipment as a negative sample.When we did the gram stain, it was full of gram negative rods.Plate seeding was performed and, in fact, gram-negative bacteria grew.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details.
Additional Manufacturer Narrative
H6.Investigation summary: a results failure was reported on a bactec fx40 instrument (p/n 442296, s/n (b)(6)).The bd remote services advised to perform a remote access and configured the sntp, after re-registering the sntp the unit was fully operative, the root cause for the false negative result is unknown.No further issues were found, this is a confirmed failure of a bd product.No physical samples were received by quality, pictures were received and an investigation was conducted.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 for this instrument was reviewed and revealed no previous cases related to this failure mode.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
Event or Problem Description
It was reported that bd bactec¿ fx40 instrument false negatives occurred.The following information was provided by the initial reporter: species: canine.Sample volume: 2.5ml (pediatric vial - peds plus/f culture vials (plastic).It is the volume.Used in the vast majority of our patients and we have never had this problem.Sample collected on 7/11 and placed in bactec on 8/11 (position a9).On 11/14 the bottle came out of the equipment as a negative sample.When we did the gram stain, it was full of gram negative rods.Plate seeding was performed and, in fact, gram-negative bacteria grew.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15956062
• Report Number: 1119779-2022-01445
• Device Sequence Number: 6655010
• 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,Followup
• Report Date (Section B): 03/06/2023

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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/16/2023; 03/06/2023
• Initial Report FDA Received Date: 12/10/2022
• Supplement Report FDA Received Date: 03/02/2023; 03/09/2023
• 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