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

Model Number 411660

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of discrepant results associated with bact/alert® pf plus (reference (b)(4)).The customer reported the bottle flagged positive after five (5) days of incubation and only 58 minutes from the end of the incubation configured period.The positive bottle was processed by culture and nothing grew on the plate at the 24 hour mark.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 will be initiated.

Manufacturer Narrative

This case was originally reported to fda as a reagent false positive case.However, after further clarification was obtained from the customer the issue was with the instrument providing a false positive result.An investigation is in-process to further assess this event.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the customer reported that un-inoculated bottle flagged positive on the instrument.A positive signal from the instrument must be confirmed by subsequent processing of the biological sample.After receiving and reviewing the instrument backup, the root cause was determined to be that six (6) new bottles were loaded in the same rack as the bottle in question.As a bottle approaches the end of its test time, it becomes more sensitive to temperature changes.Enhancements to improve temperature event robustness to address bulk loading will be included in the future virtuo software release.Note: the initial information received by the customer indicated the alleged deficiency was with the bact/alert® culture bottle; after further evaluation and investigation this complaint is associated with the bact/alert® virtuo instrument.The culture bottle and instrument are manufactured at different manufacturing sites ((b)(4), respectively); therefore, two different site ids apply ((b)(4), respectively).However, to maintain the mdr report as a single record, this follow-up remains against the initial (b)(4) number.

• Brand Name: BACT/ALERT VIRTUO INSTRUMENT
• Type of Device: BACT/ALERT VIRTUO INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7096117
• MDR Text Key: 94639745
• Report Number: 3002769706-2017-00398
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357924
• UDI-Public: 03573026357924
• Combination Product (y/n): N
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2018
• Device Model Number: 411660
• Device Catalogue Number: 410853
• Device Lot Number: 3048702
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1