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

Catalog Number	279019
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported a false negative result when using the bact/alert® bpn bottle.The bottle (id (b)(4)) was loaded on (b)(6) 2019 and flagged as negative on (b)(6) 2019.The bottle was then unloaded (b)(6) 2019, and the cell indicator was observed as yellow.The graph indicated growth and finished over 4000.The bottle was subcultured and contained facultative anaerobic gram negative sphere bacilli.The local field service engineer (fse) had previously visited the site and checked the instrument condition and found no issue.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed following a customer report of a potential false negative result when testing blood culture using the bact/alert® bpn (reference: (b)(4) blood culture bottle.A lot number for the bottle was not provided therefore a historical review for the specific lot in question could not be performed.A review of bact/alert® bpn bottle complaints was performed and determined there was no trend of false negative results for bact/alert® bpn bottles.The bpn bottle graph showed the bottle was reading the correct algorithm (h algorithm), and no instrument fault codes were present when the bottle was loaded.Global customer service and biomath also reviewed the backup data provided from the customer.This review showed the h algorithm flagged the bottle negative; however, a review of the reflectance curves showed the presence of a slow growing organism indicating the bottle was truly positive.Global customer service and biomath stated the h algorithm is not optimal for the detection of slow growing organisms.The customer did not provide additional information about the testing material or organism identification.Without this information root cause could not be determined.

• Brand Name: BACT/ALERT® BPN
• Common Device Name: BACT/ALERT® BPN
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8383610
• Report Number: 3002769706-2019-00005
• Device Sequence Number: 16657560
• Product Code: MZC
• UDI-Device Identifier: 03573026126735
• UDI-Public: 03573026126735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK050043
• 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): 10/03/2019

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 Catalogue Number: 279019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1