MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® VIRTUO INSTRUMENT

Model Number	411661
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of a false negative result associated with bact/alert® virtuo instrument (reference 411661).The customer reported that the instrument failed to flag an iqmh proficiency testing sample (bact-1710-2b candida parapsilosis) positive within five (5) days.There is no patient involvement in this event and no known adverse impact to the user.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation: an iqmh proficiency testing sample that contained, bact-1710-2b-candida parapsilosis, failed to flag positive on the bact/alert® virtuo® on (b)(6) 2017.Biomérieux received the data backup on 02may2018; however, the graphs, readings, and images of the aerobic bact/alert® fa plus bottle were no longer available due to backup storage duration design limitations.A root cause could not be determined; however, two probable root causes were identified.The provider's sample may not have been a representative sample.As previously stated, the iqmh summary challenge survey stated, six participants requested sample replacements for various reasons, which included a "no growth" investigation.Additionally, if the processing instructions were not followed, the sample may not flag positive on the bact/alert® virtuo®.Although, the backup received did not contain the required data needed to evaluate the functionality of the instrument, biomérieux reviewed documents that were available such as the audit trail, calibration reports, daily average temperature reports and hourly temperature detail report associated with the standalone a/b unit instrument.The reports did not provide evidence of an instrument malfunction.Due to the required data no longer available on the backup, biomérieux cannot further investigate this issue.

• Brand Name: BACT/ALERT® VIRTUO INSTRUMENT
• Common Device Name: BACT/ALERT® VIRTUO INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7369127
• Report Number: 1950204-2018-00117
• Device Sequence Number: 785717
• Product Code: MDB
• UDI-Device Identifier: 03573026369774
• UDI-Public: 03573026369774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161816
• 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,Followup
• Report Date (Section B): 07/30/2018

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: 411661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1