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

Catalog Number	419744
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the bact/alert® mp reagent system consists of the bact/alert® mp culture bottle with a removable closure used in conjunction with the bact/alert® mp antimicrobial supplement and the bact/alert® mp nutrient supplement.The bact/alert® mp reagent system is designed for use with bact/alert® 3d mycobacteria detection systems for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested/decontaminated clinical specimens.Issue description: a customer in the united kingdom notified biomérieux of obtaining a false negative result in association with the bact/alert® mp culture bottle (ref.419744) when testing neqas survey specimen 6675.The impacted lot number was not specified.The customer stated the bact/alert® mp culture bottle failed to detect presence of mycobacterium tuberculosis in sample 6675.The customer performed terminal microscopy and did not find presence of acid fast bacilli.The customer then repeated testing of specimen 6675 with the bact/alert® mp culture bottle; false negative result was obtained.Biomérieux customer service reviewed the survey for the uk neqas for mycobacterium culture distribution.The review confirmed specimen # 6675 contained mycobacterium tuberculosis, streptococcus mitis and streptococcus oralis.Biomérieux customer service has requested customer back-up data and additional details regarding the sample preparation and microscopy technique used.As there is no patient associated with this survey specimen, there is no adverse event related to any patient's state of health.

• Brand Name: BACT/ALERT® MP
• Common Device Name: BACT/ALERT® MP
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC
• Manufacturer (Section G): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13956156
• Report Number: 3002769706-2022-00018
• Device Sequence Number: 4882555
• Product Code: MDB
• UDI-Device Identifier: 03573026506063
• UDI-Public: 03573026506063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 419744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/30/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown