MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 320 SYSTEM; SYSTEM, BLOOD CULTURING

Catalog Number	441743
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
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.H3 other text : na.
Event or Problem Description
It was reported that while using bd bactec¿ mgit¿ 320 system, false positive result was obtained.This is a report of one occurrence, no report of adverse or injury.
Additional Manufacturer Narrative
H.6.Investigation summary: catalog # 441743, s/n (b)(6): the customer reported the generation of false positives.No patient impact was reported.The customer was provided recommendations from bd support related to the sample workflow and what may be causing the false positives.It was reported that an fse visited the site and the instrument was performing to specifications.The root cause was not determined.This complaint is not being confirmed as no instrument malfunction was identified.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no recent additional work orders were observed for the complaint failure mode reported.No samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.
Event or Problem Description
It was reported that while using bd bactec¿ mgit¿ 320 system, false positive result was obtained.This is a report of one occurrence, no report of adverse or injury.

• Brand Name: BD BACTEC¿ MGIT¿ 320 SYSTEM
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18315613
• Report Number: 1119779-2023-01363
• Device Sequence Number: 20505739
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K974883
• 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): 02/07/2024

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: 441743
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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