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 Problem Sepsis (2067)

Event Date 03/01/2021

Event Type  Death  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Mfg report # 3008352382-2021-00069 was the original report of death.This complaint is in reference to the same death event.

Event Description

It was reported that a bd bactec" fx instrument flagged false negatives on aerobic and anerobic blood culture bottles.The patient was a cancer patient that had bi-weekly blood drawn during a routine check-up.The blood was drawn from the patients port on (b)(6) 2021, and the patient expired on (b)(6) 2021 with suspected sepsis.As an internal quality control, the lab subcultures a negative bactec vial every week.One of the 4 blood cultures of this patient was sub-cultured (the anaerobic bottle) and growth of candida was seen.The other 3 vials were discarded and no additional testing could be performed.

Manufacturer Narrative

Investigation summary: complaint reference number: (b)(4) was created for a false negative result on a bd bactec fx top instrument (part number: 441385, serial number: (b)(6).The false negative result was associated with a patient death on (b)(6) 2021.The customer indicated that blood was drawn from the patient through a port before lunch on (b)(6) 2021 and used to inoculate two bd bactec lytic/10 anaerobic/f culture vials (part number: 442021, sequence numbers: 446561434519 and 446561434478) and two bd bactec plus aerobic/f culture vials (part number: 442023, sequence numbers: 449286245384 and 449286245096).The vials were placed in drawer a stations c01, d07, d06, and d04) of the instrument around 5pm.After a six day protocol, the instrument called the vials "negative".On a weekly basis, the customer indicated testing was being performed on one negative vial.One of the lytic/10 anaerobic/f vials was selected for subculture and candida albicans growth was identified.The remaining three vials could not be subcultured because they were discarded prior to observing c.Albicans growth for the fourth vial.After identifying c.Albicans growth in the lytic/10 anaerobic/f vial, the customer examined the plot for all four vials and noted exponential growth that was not flagged by the instrument.Review of the plots by a bd subject matter expert did not indicate an instrument error in calling the four vials negative.The bd bactec fx instrument detects positivity using media-specific algorithms, which looks for specific curve characteristics.In general, the algorithms look for an increase in the rate of fluorescence change that is observed in growth curves.The two curves for the plus aerobic/f culture vials (sequence numbers: 449286245384 and 449286245096), which was noted as containing exponential growth, displayed a linear increase in fluorescence from the initial reading, indicating a constant rate of change.This linear constant rate of change is different from an increase in rate of change that is observed in a growth curve.As a result, this linear constant rate of change would not have prompted a positive result call by the algorithm.In addition to plot review, a bd subject matter expert also reviewed the instrument log and database files.This review did not identify any instrument issues.A bd field service engineer (fse) was dispatched to inspect the instrument and perform preventative maintenance.During the visit, the fse checked the instrument voltages, temperature, and error logs while also inspecting the environmental condition of the laboratory.No heater, air conditioning, direct sunlight, or vibration sources were identified in close proximity to the instrument.The instrument filters were clean and the instrument was in use with approximately 180 vials.The instrument was determined to be operational and working within specification.Review of the device history record for serial number: (b)(6) revealed the instrument passed all inspection tests and was released in good condition.Service history review for serial number: (b)(6) revealed no previous complaints for results issues.The most recent complaint was reported on (b)(6) 2020 for grinding noises (b)(4), which was resolved by aligning the blower wheels in drawers a and b and replacing the blower coupling in drawer a.Preventative maintenance (pm) was previously performed on april 7, 2020 and no instrument issues were identified.A transport swab labeled as ¿candida albicans ax362510¿ was also provided for the investigation.The swab was plated and the growth were inoculated into lytic/10 anaerobic/f and plus aerobic/f vials for a five-day protocol.The aerobic vials yielded positive results and the lytic anaerobic vials were negative.All plots showed the typical positive or negative plots.The exponential growth plots observed by the customer was unable to be replicated.Bd quality did not receive any returned instrument parts for the investigation.Based on the information provided, the complaint is unconfirmed for a bd instrument failure.The root cause of the false negative result is unable to be determined.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to monitor for false negative issues on the bd bactec fx instruments.

Event Description

It was reported that a bd bactec¿ fx instrument flagged false negatives on aerobic and anerobic blood culture bottles.The patient was a cancer patient that had bi-weekly blood drawn during a routine check-up.The blood was drawn from the patients port on (b)(6) 2021, and the patient expired on (b)(6) 2021 with suspected sepsis.As an internal quality control, the lab subcultures a negative bactec vial every week.One of the 4 blood cultures of this patient was sub-cultured (the anaerobic bottle) and growth of candida was seen.The other 3 vials were discarded and no additional testing could be performed.

• 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: 11572733
• MDR Text Key: 242349741
• Report Number: 1119779-2021-00562
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/10/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death