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

Model Number	210147
Medical Device Problem Code	False Negative Result (1225)
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 false negative results associated with bact/alert® 3d instrument (reference 210147).The customer inoculated the bottle of 5ml of umbilical cord plasma from a pregnant women that wants to save the umbilical cord cells.This bottle was negative in the instrument, however the sensor looked strange so the customer subculture the bottle and received a positive result for actinomyces europaeus.There was no impact and no treatment was administered to the patient or baby.It's only to be recorded that in that sample something was detected.The bottom of this bottle shows that the sensor turns blue instead of yellow, which is why the customer knew they needed to subculture.There no additive added to the bottle only cord stem cell blood.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the investigation confirmed that the instrument performed as expected.The sample interacted with the reagent that caused the microorganism to have a biphasic growth which caused the downward slope that the algorithm is not equipped to detect.In addition, utilization of the bact/alert® sn bottle reference 259790 for this application is off-label use.The customer should utilize industry specific bottles.Bact/alert® iast, reference 259786.Bact/alert® inst, reference 259785.Finally, as this species is a facultative anaerobe, a three bottle combination is recommended for optimal detection: bact/alert® iast at 20-25°c.Bact/alert® iast at 30-35°c.Bact/alert® inst at 30-35°c.Per the industry package inserts the intended use section states the following "the laboratory is responsible for validating the bact/alert system and culture bottles for their testing purposes".

• Brand Name: BACT/ALERT® 3D INSTRUMENT
• Common Device Name: BACT/ALERT® 3D INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7489922
• Report Number: 1950204-2018-00172
• Device Sequence Number: 18915771
• Product Code: MDB
• UDI-Device Identifier: 03573026049522
• UDI-Public: 03573026049522
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: C1 EXEMPT
• 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): 08/10/2018

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: 210147
• 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: 04/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1