MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA - 10300

Model Number 10300

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: api® listeria is a qualitative standardized system for the identification of listeria.It uses miniaturized tests as well as a specially adapted database.Inoculation and reading of the strip are performed manually and the identification is obtained using an identification software.The complete list of those organisms that are possible to identify with this system is given in the technical brochure - information for identification software.Description of the issue: a customer in (b)(6) notified biomérieux of obtaining confirmation difficulties for listeria spp.When using the api listeria strips (reference 10300; lot #1008506770; expiration date : 21/12/2021).The customer has performed the aloa® one day method (a short protocol for the detection of l.Monocytogenes and listeria spp using aloa® medium) as well as a confirmation test on palcam media (recommended for the selective isolation of listeria in foodstuffs) to detect listeria spp.Summary : two (2) wipes samples, protocol checked nothing to report.- sample 1: aloa 48h of incubation, from fraser tube following re-isolation > characteristic colonies.- sample 2: aloa 48h of incubation, from fraser tube after re-isolation > atypical colonies : small dark blue.Identification on api® lis gallery gives unacceptable profiles.For both strains: gram + small bacilli, catalase +, camptest uninterpretable, haemolysis -.On palcam characteristic grey-green colonies with black halo.For both samples, the customer obtains typical colonies of listeria spp on aloa which are confirmed as listeria spp on palcam.However, the customer obtained unacceptable profiles when using the api listeria strips, and therefore no identification could have been performed with api strips.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in france notified biomérieux of obtaining confirmation difficulties for listeria spp.When using the api listeria strips (reference 10300; lot #1008506770; expiration date : 21/12/2021).Investigation the investigator reviewed batch records for lot #1008506770 (ref.10300).There was no evidence of anomalies which could explain the problem reported.Thus far, this is the only complaint documenting an issue with lot #1008506770, or on the product ref #10300 since 2019.The investigator then performed tests on a retain kit from the customer¿s lot.All results were within the specifications.The customer submitted 2 strains to the biomérieux complaints laboratory.The investigator confirmed that the profiles obtained for those 2 strains are unacceptable, on the 2 different batches of api listeria tested.Biomérieux then sequenced the strains (reference identification method).Sequencing identified the samples as cellulosimicrobium spp and cellulomonas spp; not listeria.Given that those strains are not included in the api listeria database, it is not possible to identify them with this strip.Conclusion the issue reported is not linked to a performance issue of api listeria batch 1008506770.

• Brand Name: API LISTERIA 10STRIPS+10MEDIA - 10300
• Type of Device: API LISTERIA 10STRIPS+10MEDIA
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12374826
• MDR Text Key: 283162037
• Report Number: 9615754-2021-00231
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: 10300
• Device Lot Number: 1008506770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1