MAUDE Adverse Event Report: BIOMÉRIEUX, INC. SYS-BACT/ALERT 3D 0120

Model Number	4700106
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomerieux of false negative results in association with the bact/alert® 3d instrument when performing an external quality control assessment.The customer stated their bact/alert® 3d instrument did not detect growth when testing the external quality control strains.The customer also stated the instrument has been in use since 2005 but has not performed regular maintenance on the instrument.No further information has been provided regarding the false negative results obtained by the bact/alert® 3d instrument.As there is no patient associated with this quality control survey, there is no adverse event related to any patient's state of health.
Additional Manufacturer Narrative
An investigation could not be conducted for one chinese blood bank customer complaint for bact/alert® 3d proficiency test false negative result.The customer did not provide any details or supporting data for the investigation.The investigation could not find the root cause for the false negative result because no information was provided by the customer.No specific harm to a patient was stated.A failed proficiency test could lead to a false negative result with patient samples.The customer¿s bact/alert 3d instrument was built in 2005, and there were no records showing the pm (preventative maintenance) was performed.Biomérieux recommends an annual pm for the instrument.The immediate action by biomérieux¿s customer service was to dispatch a field service engineer (fse).The fse visited the customer site and determined the instrument to be functioning normally.The bottle instructions for use (ifu), bact/alert 3d user manual, were reviewed by the investigator and deemed to have adequate directions for the user.Queries of the manufacturing data, and the complaint data do not indicate any trend related to false negative results for the bact/alert 3d or the bact/alert bpa/bpn culture bottles.Customer service reminded the customer of the resources available for troubleshooting: bact/alert culture bottle instructions for use (ifu); the bact/alert 3d user manual (document 514818-1 2015-12); 4573 - csn - bactalert - universal troubleshooting form; immediately obtain an instrument data backup, and bottle graphs (photos or printouts).Customer service also recommended the customer perform (or schedule) the following: ensure the annual preventative maintenance is performed on the bact/alert 3d; review the proficiency provider¿s instructions for the survey; ensure the correct sample volume was added to the correct bottle type for the culture test; take steps to avoid oxygenating the anaerobic bottle during inoculation; do not move bottles under test; provide customer service with the details needed to troubleshoot a false negative problem: the bottle graphs, 3d backup, proficiency provider¿s directions and summary, organism identification; culture bottle lot numbers; instrument serial number; provide photos of the bottles involved (top, side, and bottom).

• Brand Name: SYS-BACT/ALERT 3D 0120
• Common Device Name: SYS-BACT/ALERT 3D 0120
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11793789
• Report Number: 1950204-2021-00037
• Device Sequence Number: 14256898
• Product Code: MDB
• UDI-Device Identifier: 03573026047566
• UDI-Public: 03573026047566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4700106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1