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

Model Number 445870

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

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.(b)(4).

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system false negative results were obtained by the laboratory personnel.Direct auramine/ zn staining was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation summary: "a failure for false negatives was reported on a mgit 960 instrument (p/n 445870, s/n (b)(6)).The customer reported that there were an unusual number of culture negative specimens at 42 days that were positive on staining.Bd remote service determine that the issue is related to the calibrator tubes, which were recently changed, so the customer ordered new calibrator tubes were resolved the problem.This is an unconfirmed failure of a bd product.Bd quality did not receive any returned materials for review.Review of device history record for (b)(6) is not needed due to the age of the instrument.Service history for (b)(6) was reviewed and revealed no previous complaints related to false negatives.The root cause was most likely the expiration date of the calibrator tubes.

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 system false negative results were obtained by the laboratory personnel.Direct auramine/ zn staining was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.

• 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
• MDR Report Key: 11311037
• MDR Text Key: 231418671
• Report Number: 1119779-2021-00289
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): N
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1