MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BACTEC¿ FX40 INSTRUMENT; MICROBIAL GROWTH MONITOR

Model Number 442296

Device Problem False Negative Result (1225)

Patient Problem Death (1802)

Event Date 01/31/2020

Event Type  Death  

Manufacturer Narrative

Expiration date: unknown.The expiration date was not provided.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.While death was reported, there is no information provided that the patient¿s death was caused or contributed by the device.

Event Description

It was reported that a bd bactec¿ fx40 instrument flagged a false negative for an aerobic bottle with the result being reported out after the patient expired.The patient was a referral to the hospital from a lower facility, and was unconscious reaching the hospital.The blood was drawn from the patient on the (b)(6) 2020 (aerobic and anaerobic).On the (b)(6) 2020, the anaerobic vial was flagged positive by the bd bactec¿ fx40 instrument.The lab subcultured the blood, but results were not reported out.The aerobic bottle reached end of protocol on (b)(6) 2020 and when the lab followed up they learned the patient expired on (b)(6) 2020.The results were finalized on the (b)(6) 2020, positive for citrobacter freundii.

Event Description

It was reported that a bd bactec¿ fx40 instrument flagged a false negative for an aerobic bottle with the result being reported out after the patient expired.The patient was a referral to the hospital from a lower facility, and was unconscious reaching the hospital.The blood was drawn from the patient on the (b)(6) 2020 (aerobic and anaerobic).On the (b)(6) 2020, the anaerobic vial was flagged positive by the bd bactec¿ fx40 instrument.The lab subcultured the blood, but results were not reported out.The aerobic bottle reached end of protocol on 29th january 2020 and when the lab followed up they learned the patient expired on (b)(6) 2020.The results were finalized on the 31st january 2020, positive for citrobacter freundii.

Manufacturer Narrative

H.6.Investigation summary: bd diagnostic systems (bdds) quality investigated the complaint of a potential false negative result flagged by the bd bactec fx40 instrument, serial number (b)(6).Two vials (aerobic and anaerobic) were collected from a patient.The anaerobic vial was flagged as positive for bacterial growth on 27 january 2020, but laboratory personnel did not report the positive result to the doctor.On (b)(6) 2020, the patient passed away.On 29 january 2020, the aerobic vial was flagged as negative by the fx40.Confirmatory testing revealed bacterial growth in the aerobic vial, and the sample was confirmed as positive for citrobacter freundii.Citrobacter freundii is a facultative anaerobe that is capable of growth in anaerobic and aerobic conditions.Growth rates for this bacteria in the aerobic vial may be reduced, but plots were not provided to confirm this.The erroneous result did not contribute to the death of the patient, as the negative was flagged after death occurred.Log files were obtained and reviewed.A high number of power failures were observed since early (b)(6).The power failures were most likely attributed to facility power issues or a user turning the power off to the instrument.The instrument service history was reviewed.No prior occurrences of erroneous results have been documented for this instrument.The instrument received preventative maintenance in january 2019.The device history record (dhr) was reviewed.The instrument passed all inspection tests and was released in good condition.The root cause is unable to be determined.Assignable causes include: power failures due to facility power fluctuations or a user manually powering off the instrument, reduced bacterial growth in the aerobic vial, sample collection practices, and media-related issues.This is an unconfirmed failure of the instrument.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this failure.Investigation conclusion: complaint trend data was reviewed.Based on the previous 12 months of complaint data, an average of 1.33 complaints per month are received for results related complaints.Alert and action levels are 3 and 5, respectively.The hazard analysis was reviewed.This complaint is captured in baltrmbactecinstraph revision 11, under row 2.10 as an s4.No new risks or hazards or changes to existing risks/hazards were identified.No further action is required at this time.Quality will continue to monitor for related trends.Root cause description: the root cause is unable to be determined.Assignable causes include: power failures due to facility power fluctuations or a user manually powering off the instrument, reduced bacterial growth in the aerobic vial, sample collection practices, and media-related issues.Rationale: no new risks or hazards or changes to existing risks/hazards were identified.H3 other text : see section h.10.

• Brand Name: BD BACTEC¿ FX40 INSTRUMENT
• Type of Device: MICROBIAL GROWTH MONITOR
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 9758865
• MDR Text Key: 181087404
• Report Number: 1119779-2020-00003
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904422967
• UDI-Public: 00382904422967
• Combination Product (y/n): N
• PMA/PMN Number: K915796A
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 442296
• Device Catalogue Number: 442296
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death