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

Model Number	10300
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.Issue description: an industry customer in singapore notified biomerieux of obtaining "no identification" and "misidentification" results in association with the api® listeria test (ref.(b)(4), lot 1008506770).The customer stated lot 1008506770 did not identify the industry strain.The isolate was also tested on the vitek® 2 which identified the strain as listeria monocytogenes.Biomerieux customer service reviewed the provided lab reports and observed non-reactive/low reactivity on the sugar wells.The customer then tested the atcc® l.Monocytogenes isolate with lots1008506770, 1008452670 and 1008988000 incubated in two separate incubators at 35°c and 37°c.The same "no identification" results were obtained.Refer to (b)(4) and (b)(4) for the other lots.As there are no patients associated with these industry and quality control strains, there is no adverse impact to any patient¿s state of health.Biomerieux has initiated an internal investigation.
Additional Manufacturer Narrative
An industry customer in singapore notified biomérieux of obtaining no identification and misidentification results in association with the api® listeria test (ref.10300, lot 1008506770).Review of the batch records for api listeria (ref.10300; lot# 1008452670, 1008988000 and 1008506770), did not highlight any anomalies during manufacturing or quality control which could lead to an identification issue.There is neither trend of complaints on the batches (b)(4), nor on product reference 10300 regarding the issue reported.The quality control strains tested (listeria monocytogenes atcc® 19115¿ and atcc® 7644¿) on the retained sample of the batch impacted (batch 1008988000) complied with specifications.The customer confirmed (07th january 2022) that this issue was not reproduced during retesting at their laboratory with the atcc® 7644¿ strain, using batch 1008988000.The biomérieux complaint investigation laboratory was also unable to determine or confirm a root cause for this customer¿s issue.Biomérieux customer service reminded the customer of the lab protocol for misidentification or no identification issues with api listeria and/or difficulties to interpret: - check the purity of the strains tested before carrying out any identification with api listeria strips, - perform the tests with fresh strains (24 hours), - follow strictly the protocol described on the instruction for use, - respect the validated delay of storage of reagents after opening, - follow the recommendations in the iso 11133 standard regarding the conservation, preparation and subculture of collection strains (such as atcc strains).

• Brand Name: API LISTERIA STRIPS+10MEDIA
• Common Device Name: API LISTERIA STRIPS+10MEDIA
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13211971
• Report Number: 9615754-2022-00005
• Device Sequence Number: 19254260
• Product Code: JTO
• UDI-Device Identifier: 03573026035587
• UDI-Public: 03573026035587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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
• Operator of Device: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown