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

Model Number	210147
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/08/2013
Type of Reportable Event	Death
Event or Problem Description
A customer in the united states notified biomérieux of discrepant results associated with the bact/alert® unit.The customer reported an initial bottle ((b)(4)) was loaded on (b)(6) 2013 and the instrument flagged the bottle as a negative result after five (5) days on (b)(6) 2013.An analysis of the data indicates this bottle was unloaded as positive at approximately 9 hrs., but reloaded to continue testing through the five (5) day protocol.A second bottle ((b)(4)) was loaded on (b)(6) 2013 and the instrument flagged the bottle as positive at 9.36 hours on (b)(6) 2013.The organism that grew was identified as klebsiella pneumoniae.The patient is a (b)(6) year old female.The patient had been discharged from the hospital on (b)(6) 2013.On the evening of (b)(6) 2013, the patient returned to the emergency department because the cap had come off of her picc line, and was non-symptomatic.A blood draw was performed on the patient and sent to the laboratory for testing.The patient had a picc (peripherally inserted central catheter) line for administration of nourishment.The patient died on (b)(6) 2013.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation: the instrument functioned correctly, the observa backup shows bottle id spj3fb06 flagged positive.The bottle detail screen showed an unconfirmed positive check mark, which indicates the positive bottle was reloaded.The graph does not have any gaps, which indicates the user re-loaded it immediately, potentially bypassing protocols for positive bottles.The ifu (part# 9311988 rev.C) for pediatric charcoal bottles states to 'smear and subculture all positive bottles.If the smear is negative, indicating a possible false positive, the bottle should be reloaded into the instrument until growth of the subculture or redesignation as positive.Bottles that were initially determined false positive and were redesignated positive, should be smeared and subcultured.'.

• Brand Name: BACT/ALERT® 3D
• Common Device Name: BACT/ALERT® 3D
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 6898368
• Report Number: 1950204-2017-00317
• Device Sequence Number: 872570
• Product Code: MDB
• UDI-Device Identifier: 03573026049522
• UDI-Public: 03573026049522
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K903505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/29/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 2 YR