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

An industry customer in (b)(6) notified biomérieux of the misidentification of listeria monocytogenes as listeria welshimeri in association with the api® listeria 10strips+10media (ref.10300, lot 1007599020).The customer initially cultured the isolate using tsaye and blood agar; an isolate from the tsaye agar was used for identification testing on the api ®listeria strip.The api listeria strip identified the isolate as listeria welshimeri, a non-hemolytic organism.The customer observed beta hemolysis on the blood agar plate; this result contradicted the listeria welshimeri identification provided by the api listeria strip.Biomérieux customer service advised the customer to test the isolate cultured from blood agar and to also test reference sample atcc® 15313 listeria monocytogenes.The customer repeated this test a total of three (3) times, each time the customer sample was identified as listeria welshimeri and the reference sample obtained the correct identification of listeria monocytogenes.The isolate was sent out for identification sequencing and was identified as listeria monocytogenes.As there is no patient associated with this industry sample, there is no adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of the misidentification of listeria monocytogenes as listeria welshimeri in association with the api® listeria 10strips+10media (ref.10300, lot 1007599020).The customer was unable to return the strain, so investigational testing was performed using qc strains.The qc strains were tested on the customer's lot (1007599020) and a reference lot (1007636960).---investigational testing--- listeria innocua atcc 33090 (cq173) - 1 strip per lot.Listeria ivanovii atcc baa-139 (cq210) - 1 strip per lot.Listeria monocytogenes atcc 19115 (cq211) - 3 strips per lot.For each strain, results were compliant with quality control procedure specifications for the investigated lot (batch 1007599020) and the reference lot (1007636960).There is no difference between the investigated lot and the reference lot.---complaint trend analysis--- a review of all complaints associated with ref (b)(4) since 2017 did not identify any trends for this type of issue.---batch record review--- no non conformities were identified related to the batch record of the finished product lot 1007599020.---conclusion--- the results from this investigation did not identify any performance issues with the lot used by the customer and the results for the customer lot were in alignment with the reference lot.The investigation concluded that the customer's strain is possibly an atypical strain of listeria monocytogenes, but this cannot be confirmed as the customer was unable to provide the strain for the investigation.

• 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: 9885484
• MDR Text Key: 227951758
• Report Number: 9615754-2020-00051
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• PMA/PMN Number: C 1 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: 07/10/2020

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: 05/16/2020
• Device Model Number: 10300
• Device Catalogue Number: 10300
• Device Lot Number: 1007599020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1