MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING

Model Number 441385

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

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.A subculture was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H6: investigation summary: customer reported false positive issue on a bd bactec fx top instrument (p/n 441385, s/n (b)(6)).No erroneous results were reported to doctors, and patients were not impacted.A bd field service engineer (fse) was dispatched and identified that the indoor temperature raised from 28 degrees to 31 degrees due to the air conditioner in the hospital and maintained for about 4 hours.Drawer a and b¿s temperature was more than 36 degree centigrade and more than 2 hours which were contributed to false positives.The fse resolved the ac problem and operated the ac to keep the room temperature below 25 degrees for normal operation.Review of the device history record is not required due to the age of the instrument.Service history record review revealed no previous complaints for this issue.Bd quality did not receive any returned parts or instrument for investigation.This complaint is an unconfirmed failure of a bd product.The root cause is indoor temperature.No new trends, risks, or hazards were identified as a result of the complaint.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.A subculture was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD BACTEC FX, INSTRUMENT TOP, PACKAGED
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11381747
• MDR Text Key: 245611189
• Report Number: 1119779-2021-00386
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• PMA/PMN Number: K915796
• 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: 05/18/2021

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: 441385
• Device Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1