MAUDE Adverse Event Report: BIOMÉRIEUX, INC. CONTROL MODULE PKGD 3D - 210147

Model Number 210147

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

Product description.The bact/alert® 3d microbial detection system is an automated test system capable of incubating, agitating, and continuously monitoring aerobic and anaerobic media inoculated with patient specimens suspected of having bacteremia, fungemia, and/or mycobacteremia.Complaint description.A customer in portugal complained after having obtained false negative results when testing four bact/alert® bottles (two fa plus and two fn plus) inoculated with one patient sample in association with their control module pkgd 3d (ref (b)(4), serial (b)(6).The customer indicated that they had inspected the bottles unloaded after five days' of incubation and the sensor was not yellow.Lot information of the fa plus and fn plus were not available at the time of this global assement.The customer said that before incubating the bottles inoculated with the patient's sample in their bact alert instrument, they had subcultered the content of the bottles onto different media (todd hewitt, columbia blood agar and polyvitex chocolate) and that after incubation they had observed a bacterial growth that was identified as streptococcus pneumoniae.No further details were provided.The customer mentioned that the concerned patient was a 21-week pregnant woman who lost her baby and that she was under ceftriaxon treatment.There is no indication or report from the customer that the false negative results have led to or contributed to a death, serious injury, or serious deterioration in the state of health for the concerned patient.

Manufacturer Narrative

Following the false negative results observed by the customer when testing four bact/alert® bottles (bact/alert® fa plus aerobic culture bottle reference number 410851, lot number 0004101676 expiry 31 mar 2024 and the bact/alert® fn plus anaerobic culture bottle reference number 410852, lot number 0004060148, expiry 14 apr 2024) inoculated with one patient sample, an investigation has been carried out at biomérieux manufacturing site.The customer provided the system backup and some bottle images for investigation.Review of the system backup confirmed that there were no instrument and operator error faults that might have contribute to the false negative culture bottle results.As part of the investigation of the customer complaint biomath was consulted to review the raw reflectance data (bottle readings) and it could be determined that the bact/alert 3d instrument algorithms flagged all four of the bottles correctly as negative which coincided with the instrument results.All bottles under question were not considered delayed entry and had proper volume fill.Complaints trend analysis was performed and no general trend was identified.Bact/alert® fa plus (part number 410851) instructions for use (document 043784-03 2020-02) and bact/alert® fn plus (part number 410852 043785-01 2020-08) instructions for use (document 043260-01 2020-08) read: on rare occasions organisms may be encountered that grow in the bact/alert® fa plus / bact/alert® fn plus culture bottle growth media but do not produce sufficient carbon dioxide to be determined positive.A factor that may lead to this situation is the presence of active antibiotics in a sample.Negative cultures may be checked by smear and/or gram subculture at some point prior to discarding as negative.The investigation did not find that the bact/alert® 3d instrument nor bact/alert® fa plus and fn plus culture bottles were the root cause for the reported issue.There was no evidence the bottles or instrument malfunctioned nor was there any indicated operator error.The patient also was not on any inhibitory antibiotics at the time of testing.The organism growth after reviewing the provided data was very low based on the isolation of one colony from the subculture performed before loading the bottle.The fastidious nature of the organism and low number of organisms below the limit of detection in the sample are thought to relate to the most likely root cause but cannot be confirmed.Requested action for local customer service share with the customer that subculturing negative bottles before loading may disturb the headspace gases and vent the bottles to room air and may introduce microbial contaminants.This action may cause false results.

• Brand Name: CONTROL MODULE PKGD 3D - 210147
• Type of Device: CONTROL MODULE PKGD 3D - 210147
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: stefania ciranda ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18381963
• MDR Text Key: 331182829
• Report Number: 1950204-2023-00013
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026049522
• UDI-Public: 03573026049522
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K981736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: Health Professional
• Device Model Number: 210147
• Device Catalogue Number: 210147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female