MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT 3D INSTRUMENT; BACT/ALERT® 3D INSTRUMENT

Model Number	210161
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
An industry customer in (b)(6) notified biomerieux of obtaining a false negative result while testing cord blood using the bact/alert® sn blood culture bottle (ref.259790, lot 1053744) and the bact/alert® 3d instrument (ref.210161, serial (b)(4)).The customer stated the bact/alert® sn blood culture bottle was incubated for fourteen (14) days and obtained negative result on bact/alert® 3d instrument.However, upon removal of the bottle from the instrument, the customer noticed the bottle contents were turbid and the sensor was yellow.The customer subcultured and identified the bottle contents.An identification of clostridium clostridioforme was obtained.Biomerieux customer service reviewed the bottle graph data and determined the graph is flat until day five (5), then began to increase slowly over the next three (3) days with another increase at day twelve (12).However, the growth was not sufficient to trigger the algorithm to flag the bottle positive.There was no patient involvement as this is an industry customer; therefore there is no adverse impact to any patient's state of health.Biomerieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in hong kong regarding a false negative result while testing cord blood using the bact/alert® sn blood culture bottle (ref.(b)(4), lot 1053744) and the bact/alert® 3d instrument (ref.(b)(4), serial (b)(6)).The customer stated the bact/alert® sn blood culture bottle was incubated for fourteen (14) days and obtained negative result on bact/alert® 3d instrument.However, upon removal of the bottle from the instrument, the customer noticed the bottle contents were turbid and the sensor was yellow.The customer subcultured and identified the bottle contents.An identification of clostridium clostridioforme was obtained.Biomerieux customer service reviewed the bottle graph data and determined the graph is flat until day five (5), then began to increase slowly over the next three (3) days with another increase at day twelve (12).However, the growth was not sufficient to trigger the algorithm to flag the bottle positive.A biomérieux internal investigation was completed but no definitive root cause for the false negative result could be determined.No adverse trend was found in the complaint data for this organism or bact/alert sn lot number.Since c clostridioforme, is a strict anaerobe, an introduction of air caused by using a larger needle gauge could have prevented the organism from growing.Customer service requested troubleshooting information about the customer's inoculation technique and the size of the needle used but no additional information was received.In addition, the data backup from the customer's bact/alert 3d system was not received for analysis.

• Brand Name: BACT/ALERT 3D INSTRUMENT
• Common Device Name: BACT/ALERT® 3D INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood, mo
• MDR Report Key: 10018847
• Report Number: 1950204-2020-00130
• Device Sequence Number: 11589084
• Product Code: MDB
• UDI-Device Identifier: 03573026049591
• UDI-Public: 03573026049591
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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 Model Number: 210161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1