MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT FN PLUS; BACT/ALERT® FN PLUS

Catalog Number	410852
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of duplicate bottle barcode in association with the bact/alert® fn plus blood culture bottle (ref.410852, lot 4053900).The customer stated that they loaded the inoculated bact/alert® fn plus blood culture bottle onto the bact/alert® 3d instrument; the instrument immediately registered the bottle as negative.The bottle was ejected upon identifying the duplicate bottle barcode.The user must reload the bottle with a generic bottle label in order for it to be fully processed.There is no indication or report from the laboratory that the duplicate label or early bottle ejection led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
A customer in japan notified biomérieux of duplicate bottle barcode in association with the bact/alert® fn blood culture bottle (ref.259793, lot 4053900).An investigation was conducted by biomérieux.Examination of the data backup submitted by the customer indicated that the issue was not due to a duplicate bottle barcode.The data backup details confirmed that the user did not follow the bact/alert® 3d instrument user manual (514818-1en1 - 2015-12 - en - bact/alert 3d - b.50) instructions for unloading and reloading anonymous bottles.Based on the investigation, the user resolved the issue within 20 minutes of observing the associated error 913 message.There was no impact to the bottle testing or results.The data backup showed three anonymous bottle loads, and unloads.Two bottles, (b)(6), were reloaded successfully.The error 913 occurred when the customer attempted to reload the third bottle.This is typical for two-handed loading, where the user is holding two bottles, one in each hand, and scans one but loads the other.None of the bottle ids around this sequence of events were found in the database previously; the event log goes back to (b)(6) 2015.The last load event shows the user resolved the problem by using a 'custom' bottle id (b)(6).The bact/alert 3d instrument user manual contains the following caution statement: "in order to preserve test data integrity, handle only one bottle at a time.It is important to complete the procedure for each bottle before proceeding to the next bottle." the bact/alert 3d instrument and fn culture bottle performed as intended.See section h10 h3 other text : device not returned to manufacturer.

• Brand Name: BACT/ALERT FN PLUS
• Common Device Name: BACT/ALERT® FN PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 10001207
• Report Number: 3002769706-2020-00008
• Device Sequence Number: 3318896
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121455
• 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): 09/17/2020

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 Expiration Date: 05/21/2020
• Device Catalogue Number: 410852
• Device Lot Number: 4053900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1