MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT® CONTROL MODULE PKGD 3D

Model Number	210147
Medical Device Problem Codes	No Device Output (1435); Device Inoperable (1663)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) reported to biomérieux a product problem in association with bact/alert® control module pkgd 3d.On (b)(6) 2016 the staff in the bacterial screening lab in (b)(6) noticed that the controller unit on system c had gone blank, although the incubators could still be heard agitating.On (b)(6) the customer identified that there were data gaps in the records.This exposed a risk that the initial negative result observed in the data manager on (b)(6) was not a real negative result - and thus there was a lower confidence in the bacterial status of all the platelets that were under test in this system.The customer reported the incident to the medicines & healthcare products regulatory agency mhra through sabre - serious adverse blood reactions and events (on line reporting system).The file number is sabre ref.2016/012/030/hv1/002.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation has been initiated and a 3d backup has been requested.
Additional Manufacturer Narrative
This report was initially submitted following notification that a customer in the (b)(6) reported the occurrence of potential false negative results in association with the bact/alert® 3d system.On-site troubleshooting and investigation by the field service engineer (fse) determined the internal ups (uninterruptable power supply) battery failed.The fse replaced the battery, confirmed operation, and returned the system to the customer for routine use.In addition, it was identified that the ups is recommended for replacement every two years; the battery in question had not been replaced for three years.A label was applied to the instrument chassis indicating the due date of the next required battery replacement.

• Brand Name: BACT/ALERT® CONTROL MODULE PKGD 3D
• Common Device Name: BACT/ALERT® CONTROL MODULE PKGD 3D
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 6450094
• Report Number: 1950204-2017-00106
• Device Sequence Number: 587974
• Product Code: MDB
• UDI-Device Identifier: 03573026049522
• UDI-Public: 03573026049522
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K903505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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: 210147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1