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

Model Number 210147

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Intended use: bact/alert® virtuo® microbial detection system is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids and from blood platelet samples.Issue description: a customer (blood bank) in the united kingdom notified biomérieux of a potential instrument false positive result in association with control module pkgd 3d (ref.210147, serial number (b)(4)) which is part of bact/alert® virtuo® system.It was reported that a blood center customer experienced a positive result on a sample.The result has not been confirmed as positive and the customer stated the subculture confirmation may take a few weeks to receive.It was reported that once a sample becomes a positive on the bact/alert® system, signapps emails are sent automatically to bacterial screening and the issuing department and this triggers the recall process, so it was confirmed that this false positive has been recalled.However, recovering the platelet units for them to be sent for bacteriology testing is dependent on their location at the time of the positive.There were two units associated with this donation.At the time of the positive result, one was still in nhsbt and was sent to bacteriology lab to be tested; the other was already transfused.Hospitals have their own processes management on what to do if a platelet becomes positive after transfusion.It normally involves monitoring the patient and/or giving antibiotics/medication if they have a reaction or are immunocompromised, etc.The result was found to be positive within the normal time frame but had already been sent out.There is no indication or report from the customer that this event led to any adverse event related to the patient's/user¿s state of health.An investigation will be initiated.

Manufacturer Narrative

Context: a customer (blood bank) in the united kingdom notified biomérieux of a potential instrument false positive result in association with control module pkgd 3d (ref.(b)(4) , serial number (b)(6) ) which is part of bact/alert® virtuo® system.Complaint investigation inv-(b)(4) was initiated in response to one customer complaint relating to one instrument false positive bact/alert® bpn culture bottle with id pn (b)(4) inoculated with an apheresis platelet sample on their bact/alert® 3d version b.40.51 instrument with control module serial number (b)(4).The complaint is from an industry blood bank customer.Investigation: batch history record and trend analysis.Non-conformances during manufacturing and during our quality control processes that could explain the issue were not identified.There is no capa related to the customer¿s complaint recorded.Queries of the manufacturing data, and the complaint data do not reveal any adverse trend for loose racks.Investigation results.The bact/alert 3d backup was reviewed for bottle movement, fault codes, temperature issues and loading / unloading events that might have impacted the bottle readings causing the instrument to flag the bottle positive.The customer indicated to customer service that the rack was loose and during inspection the field service engineer (fse) discovered the rack mount was broken and the mounting screw had fallen out.The fse replaced the broken rack and checked the additional racks and screws to ensure they were secured properly.The root cause for the false positive bottle was determined to be that the broken rack was impacting the bottle in cell location 5a53 causing shifts in the bottle¿s graph that triggered an instrument positive flag.The annual pm (preventive maintenance) procedure directs the fse to check and replace the rack mounting screws if they are loose.The customer indicated while printing the bottle's graph they spotted gaps in the graph but did not receive any fault codes.Review of data from the instrument backup showed the bottle readings were present for all 10-minute intervals during the incubation period, therefore the graph shows jumps between readings and not gaps or missing reads in the data.The data backup shows the following false positive rate of (b)(4).At the site.The rate of false positives with this product type experienced by the customer is within the expected rate defined in the bpn culture bottle instructions for use.The root cause for the broken rack mount is not known, but possibly could be related to a bottle not being pushed in and the drawer being forced closed/open, or the mount screw coming loose leading to instability of the rack while it is agitating.The immediate action of the customer was to recall the (b)(4) platelet units associated with this one bpn culture bottle.No harm to a patient/recipient was stated.There is no impact to a patient because the platelet bottles involved in the complaint under investigation were instrument false positives where no organism is present.The impact to the customer is that instrument false positives require more resources to perform the gram stain and subculture.They may perform extra testing.The blood bank must notify the hospital if the unit has been dispatched or transfused before the gram stain and subculture results are known.Prior to release the blood bank may discard the unit.The impact to business is that the extra work and discarding of platelet units is expensive.Also, if the demand for platelet units is high, discarding platelet units further reduces the supply.The risk assessment determined the risk to patient/recipient was low.Conclusion: the investigator recommends the customer update to the current version for bact/alert 3d, which is version b.50 and to notify their biomérieux local customer service if they find any loose racks in the instrument.

• Brand Name: CONTROL MODULE PKGD 3D
• Type of Device: CONTROL MODULE PKGD 3D
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15234101
• MDR Text Key: 305435383
• Report Number: 1950204-2022-00026
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026049522
• UDI-Public: 03573026049522
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K903505
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 210147
• Device Catalogue Number: 210147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1