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

Model Number	200290
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal biomérieux investigation was performed and a root cause identified.The root cause for the false positive/negative results was that the customer was using fan plus media and the lis had not been updated to accommodate this media.The reason why the lis wasn't updated was due to the fact that the customer letters were sent far in advance of the customer upgrading to fan+ media.With any bottle running on the incorrect algorithm, there is a potential for incorrect results.Bactt/alert® 3d firmware release b.50 was launched in june 2016, and will help mitigate this issue by ensuring that the instrument is running on the correct algorithm based on the bottle id code.Mandatory action required (mar 3115) was issued on 20oct2016 that instructed the subs/distributors to send letters to the existing fan+ customers and also to any customers planning to begin testing with the fan plus media.
Event or Problem Description
A customer in (b)(6) notified biomérieux of a bact/alert® 3d instrument (udi# (b)(4)) that was processing bottles utilizing an incorrect bottle type, generic instead of fan plus.The bottle type is being sent from the customer's lis, which is not a biomérieux product.A review of the instrument back-up was performed by gcs.During this review, it was noted that the bottle was being scanned into the system by the user and was registering as the proper bottle type.Then the lis was transmitting the information and the bottle type was being overwritten with the generic bottle type.The customer was informed that for 17 bottles with negative results per the analysis, re-calculations were done and those bottles had a positive status.Again, the customer reported noticing some bottles not having correct types and indicated they manually corrected them.The customer reported coming across some false negative bottles and false positive bottles, but they were always monitoring their graphs and gram staining the suspicious bottles.If the result was false, they were re-incubating the bottle in the instrument.The customer also stated there were no complaints from physicians regarding inaccurate test results.The customer later reported the issue with the lis bottle type was resolved as the lis vendor performed changes to the hard coding.The bact/alert® system is operating as intended and configured.

• Brand Name: BACT/ALERT® 3D
• Common Device Name: BACT/ALERT® 3D
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 6428099
• Report Number: 1950204-2017-00095
• Device Sequence Number: 16294518
• Product Code: MDB
• UDI-Device Identifier: 03573026047566
• UDI-Public: 03573026047566
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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: 200290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1