MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING

Model Number 445870

Device Problem Patient Data Problem (3197)

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

Event Date 08/30/2021

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.Medical device expiration date: na.(b)(6).

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system mis-association was observed by the laboratory personnel.A manual test was used to confirm the results.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " suspected false positive, lis mis transfering".

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system mis-association was observed by the laboratory personnel.A manual test was used to confirm the results.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " suspected false positive, lis mis transfering".

Manufacturer Narrative

H6: investigation summary a failure was reported on a mgit 960 instrument (p/n 445870, s/n (b)(6) customer indicated that they are suspected the false positives, lis misreferring.A bd field service engineer (fse) was check the data log and identified as operation error.This is an unconfirmed failure of a bd product.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.Device was installed on 6/5/2015.Service history review was performed for the instrument (b)(6) and no additional work orders were observed for the complaint failure mode reported.Bd quality did not receive samples for this investigation.The root cause was customer workflow induce.

• Brand Name: BD BACTEC¿ MGIT¿ 960 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12537446
• MDR Text Key: 280697664
• Report Number: 1119779-2021-01576
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Operator: Other
• Device Model Number: 445870
• Device Catalogue Number: 445870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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