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

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 it is possible to identify with this system is given in the technical brochure - information for identification software.Incident description: a customer in (b)(6) reported to biomérieux discordant results (potential misidentification) in association with the product api listeria 10strips+10media (ref 10300, batch 1008392040, expiry date 15-oct-2021) with an external quality assessment (eqa) sample.The customer has tested an atcc strain (atcc reference not reported) with mini-vidas, with api listeria as confirmation method and another method for identification (method and results not reported): he reported that he obtained discrepant results.It is suspected that there was an user error regarding the zym b (reagent used for test reading and interpretation): it was reported that they used zym b, 46 and 64 days after opening for some strips, whereas it is important not to use zym b after 15 days, or it would affect the results.Moreover in this context there are potential false results due to potential erroneous interpretation for which the customer requested assistance to biomerieux customer service.At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.An investigation will be initiated.

Manufacturer Narrative

A customer in colombia reported to biomérieux discordant results (potential misidentification) in association with the product api listeria 10strips+10media (ref (b)(4), batch 1008392040, expiry date 15-oct-2021) with an external quality assessment (eqa) sample.Investigation: the investigator reviewed the device history record.This review did not highlight any anomalies during manufacturing or quality control which could lead to an identification issue.There are also no capas, nor non-conformities on api listeria (ref.(b)(4); lot# 1008392040), linked with customer complaint.The quality control strains tested on the retained sample complied with specifications for the impacted lot number 1008392040.No identification issue was observed on the impacted lot number 1008392040 with the listeria monocytogenes atcc® 35152¿ strain tested, and there was no issue with the dim test interpretation (the color observed was pale orange).The investigator was unable to reproduce or confirm the customer¿s report.Conclusion local customer service reminded the customer of steps to help avoid misidentification or "no identification" issues with api listeria and/or difficulties to interpret the dim test color.They asked the customer to 1) check the purity of the strains tested before carrying out any identification with api listeria strips, 2) perform the tests with fresh strains (24 hours), 3) respect the validated delay of storage of reagents after opening (up to 2 weeks for zym b), and 4) respect recommendations mentioned in the iso 11133 standard regarding the conservation, preparation and subculture of collection strains (such as atcc strains).

• 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 les grottes 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3, route de port michaud; la balme les grottes
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12457290
• MDR Text Key: 280689401
• Report Number: 9615754-2021-00238
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Model Number: 10300
• Device Catalogue Number: 10300
• Device Lot Number: 1008392040
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Type of Device Usage: A
• Patient Sequence Number: 1