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

Model Number 441743

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/07/2022

Event Type  malfunction  

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 Description

It was reported while testing with bd bactec¿ mgit¿ 320 system false positive results were obtained.Confirmatory testing was performed using retesting.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: it was reported that working with for issues documented on case (b)(4) indicated having issues with results from this instrument.Indicated that on multiple occasions this instrument has provided discrepancies where three samples from the same patient shows a positive and two negatives.Indicated that the instrument shows no errors.Dispatch requested.Issues with results.

Event Description

It was reported while testing with bd bactec¿ mgit¿ 320 system false positive results were obtained.Confirmatory testing was performed using retesting.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: it was reported that working with for issues documented on case (b)(4) indicated having issues with results from this instrument.Indicated that on multiple occasions this instrument has provided discrepancies where three samples from the same patient shows a positive and two negatives.Indicated that the instrument shows no errors.Dispatch requested.Issues with results.

Manufacturer Narrative

H.6 investigation summary: this complaint alleges a failure on a mgit 320 instrument (p/n 441743, (b)(6)).Ta field service engineer (fse) was dispatched to inspect the instrument.The fse inspected the instrument and found no issues.The fse confirmed that the calibrator tubes were not expired but did determine the customer was not informing the instrument of the calibration replacement.No samples or parts were returned for this complaint and thus, returned sample analysis cannot be completed.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 failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument (b)(6) and no additional work orders were observed for the complaint failure mode reported.Root cause is unknown at this time.This is an unconfirmed failure of a bd product.Complaint history for results was reviewed for the month of june.The upper control limit was not breached, and trends were not identified associated with this defect.No new trends, risks, or hazards were identified as a result of this complaint.This complaint will be included in the periodic trend review.Per baltrm-mgit320_960-aph revision 5, the hazard associated with this complaint is false positive, which is an s3; reference row id 2.1.

• Brand Name: BD BACTEC¿ MGIT¿ 320 SYSTEM
• Type of Device: 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: 14918722
• MDR Text Key: 303836515
• Report Number: 1119779-2022-00955
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: 00382904417437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441743
• Device Catalogue Number: 441743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1