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 organisms that it is possible to identify with this system is given in the associated technical brochure - information for identification software.Incident description: on the (b)(6) 2021, a customer in (b)(6) reported to biomérieux a potential misidentification with the product api listeria (ref 10300, batch 1008506770, expiry date 21-dec-2021) with an external quality assessment (eqa) sample.The customer tested an eqa sample, 20a round ma191, from lgc and has reported an issue with the confirmation part of the test.A confirmation using api listeria was performed and for all analysts, the result was very good identification of listeria grayi 99.8%.Based on the report from lgc: this sample contained a ¿-haemolytic strain of listeria innocua; 46.7% of participants incorrectly reported the presence of listeria monocytogenes.This strain was obtained for use in the mars wrigley pt scheme and has undergone whole genome sequencing and identified as listeria innocua, the data provided being compliant with mars wrigley requirements.Results for the detection of listeria species were 96.3% correct, indicating no issue with the quality of the sample batch and that an incorrect result is likely to be due to identification or confirmatory issues.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation will be initiated.

Manufacturer Narrative

A customer in ireland notified biomerieux of obtaining a potential misidentification in association with api® listeria (ref 10300; lot# 1008506770; exp.21-dec-2021) with an external quality assessment (eqa) sample.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.The lot was released for distribution on 29th of january 2021.786 kits were produced and released.Review of the complaints database showed this to be the first complaint registered for lot# 1008506770.This is also the first complaint registered for misidentification of listeria innocua since the 1st of january 2019.The database for api listeria v2.0 was also checked to identify any potential discriminant test between l.Grayi and l.Innocua strains.One test is identified as discriminant : rib which is at 100% for l.Grayi and 0% for l.Innocua.The profile obtained with the strain isolated from lgc sample (api profile 7130) for the rib test can explain the misidentification between l.Grayi and l.Innocua.Biomérieux tested the performances of api listeria kit batch 1008506770 using retain samples of lots #1008506770 (exp.21 dec 2021; the customer¿s lot), and #1008392040 (exp.15 oct 2021; used as reference lot).Four strains were tested (according to our quality control procedure): 1) l.Innocua atcc® 33090¿ : strain included in the package insert 07887 t; 2) l.Ivanovii atcc® baa-139¿ : strain included in the package insert 07887 t; 3) l.Monocytogenes atcc®19115¿ : strain included in the package insert 07887 t; 4)l.Grayi atcc® 19120 : strain included in the quality control procedure.One strip per strain and per lot was tested.The strains tested gave results that were consistent compared to the theoretical profiles for the two (2) lots tested.No issue observed on the lot related to the complaint particularly for the l.Innocua strain tested (atcc® 33090¿).No issue observed on rib test during this investigation : rib test is confirmed as the discriminant test between l.Grayi and l.Innocua.Biomérieux did not observe any performance issue related to the lot #1008506770.On the 5th of august 2021 the complaint investigator received one tube identified "l innocua m hem".The strain was subcultured on colombia+5% sheep blood agar under aerobic atmosphere (subculture of 18-24h at 37°c).We used maldi-tof vitek® ms v3 (knowledge base v3.2) to confirm strain identification as l.Innocua (with 99.9% confidence).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: l.Innocua atcc® 33090¿; l.Ivanovii atcc® baa-139¿; and l.Monocytogenes atcc® 19115¿.All strips tested obtained the correct identification and the results were identical when comparing batch 1008288190 and batch 1008038660.Biomérieux 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.Lot testing: using api listeria strip (ref 10300), the investigator tested three (3) strains : 1) strain "l innocua m hem" received from the customer; 2) atcc® 19120¿ (cq168)- l.Grayi; and 3) atcc® 33090¿ (cq173) - l.Innocua.The strains were tested with the customer¿s stated lot of api listeria kit (batch : 1008506770) in parallel with an internal reference lot (batch : 1008392040).One strip per strain and per batch.For atcc® 19120¿ (cq168, listeria grayi) and atcc® 33090¿ (cq173, listeria innocua), the profiles obtained are in agreement with the quality control specifications.No problems of discrimination between the organisms were found.The "l innocua m hem" sample from the customer was also tested.Both the customer¿s lot and the reference gave good identifications to l.Grayi (99.8%), confirming the customer¿s report.The comparison of biochemical profiles was performed between the customer¿s api results, and the results we obtained in our laboratory with the customer's strain and the expected profiles of l.Innocua and l.Grayi.The ribose test is usually used to distinguish between both species.The rib result was positive for the "l innocua m hem" strain which explains the identification as l.Grayi.Conclusion.Based on all above elements, biomérieux confirmed the customer¿s issue.The biochemical profiles analysis confirms that the customer¿s sample is a l.Innocua with an atypical positive rib test.A change request has been registered to request an update of our api database for the next release to avoid such misidentifications (cr-306 ¿ apikb update) by taking into account that some strains of l.Innocua produce positive rib test results.

• 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
• MDR Report Key: 11995421
• MDR Text Key: 281523831
• Report Number: 9615754-2021-00175
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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 Catalogue Number: 10300
• Device Lot Number: 1008506770
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1