MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA; API® LISTERIA 10STRIPS+10MEDIA

Model Number 10300

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of misidentifications of listeria monocytogenes when testing two (2) strains with api® listeria 10strips+10media (ref 10300, lot 1007942830).The listeria monocytogenes strains included one (1) isolated from food samples and one (1) internal l.Monocytogenes qc strain (atcc® 13932¿).Api obtained listeria welshimeri and listeria innocua as significant taxon for the strain isolated from food samples and listeria welshimeri as significant taxon for the qc strain.The expected identification of listeria monocytogenes was confirmed by a reference lab with pcr and sero-type identification.There is no patient involved as food and qc strains are impacted.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in switzerland regarding misidentifications of listeria monocytogenes when testing two (2) strains with api® listeria 10strips+10media (ref 10300, lot 1007942830).The listeria monocytogenes strains included one (1) isolated from food samples and one (1) internal l.Monocytogenes qc strain (atcc® 13932¿).The investigation included batch record analysis.There were no nonconformities observed related to the subject lot.Quality control results were in compliance with specifications for batch release.Internal testing was performed on api® listeria 10strips+10media lot 1007942830 (related to the complaint) and lot 1007999710 (used as a reference lot).Three (3) strains mentioned in the package insert api listeria 07887 t, and one (1) strain from r&d (atcc® 13932¿) were tested on the lots.There were no performance issues or identification errors observed during testing.The customers misidentification was not reproduced.

• Brand Name: API LISTERIA 10STRIPS+10MEDIA
• Type of Device: API® LISTERIA 10STRIPS+10MEDIA
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10398218
• MDR Text Key: 205481331
• Report Number: 9615754-2020-00135
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2021
• Device Model Number: 10300
• Device Catalogue Number: 10300
• Device Lot Number: 1007942830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1