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 a misidentification of listeria monocytogenes as listeria welshimeri when testing an external quality control strain with api® listeria strips (ref.10300, lot 1008288190).The customer stated that he repeated the testing with the same sample and with another sample, and still obtained the same misidentification.A listeria monocytogenes must be negative for the tests dim / xyl and tag, but the customer obtained positive results which led to the identification as l.Welshimerii.There is no patient associated with this external survey isolate.Therefore, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

Biomerieux conducted an internal investigation in response to a customer complaint of the misidentification of a quality control listeria monocytogenes isolate as listeria welshimeri in association with the api® listeria 10 strips (ref.(b)(4), batch 1008288190).The customer was not able to submit the isolate for the investigation.The analysis of the batch history records showed no anomalies during the manufacturing, quality control, or packaging processes that would contribute to the customer¿s misidentification result.Biomerieux performed investigational testing using customer batch 1008288190 and reference lot 1008038660.One test strip from each lot was tested using the following quality control strains included in the package insert: listeria innocua atcc® 33090¿ , listeria ivanovii atcc® baa-139¿, listeria monocytogenes atcc® 19115¿.All strips tested obtained the correct identification; identical results were obtained when comparing batch 1008288190 and batch 1008038660.Biomerieux was unable to repeat the misidentification result obtained by the customer.The investigation data supports that api® listeria 10 strip batch 1008288190 is functioning as intended.

• 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: 11230909
• MDR Text Key: 239267039
• Report Number: 9615754-2021-00011
• 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: 03/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 10300
• Device Catalogue Number: 10300
• Device Lot Number: 1008288190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1