MAUDE Adverse Event Report: BIOMÉRIEUX, SA API 20 C AUX 25 STRIPS+25MEDIA - 20210

Model Number	20210
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: api® 20 c aux is a qualitative standardized system for the precise identification of the most frequently encountered yeasts.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.Description of the issue: a customer from the united states notified biomérieux of quality control test failure with cyptococcus laurentii atcc® strain when using the product api® 20 c aux (reference 20210 - lot 1008311320 - expiration date : 23/03/2022).The api® 20 c aux did not produce a turbid (positive) result for the mdg well as expected.Per the instructions for use (ifu), cryptococcus laurentii atcc® 18803¿ present positive reactions for all wells except for gly and tre.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united states notified biomérieux of quality control test failure with cryptococcus laurentii atcc® strain when using the product api® 20 c aux (reference 20210 - lot 1008311320 - expiration date : 23/03/2022).Investigation: the investigator conducted a batch record review of api 20 c aux (ref.(b)(4), batch 1008311320).This did not highlight any anomalies during manufacturing or quality control which could lead to identification issues.Retained sample testing: the tests performed on the retained sample of batch 1008311320 showed results for the three strains tested, with no difference between the investigated batch and the reference batch.In particular, mdg test showed positive result for the strain cryptococcus laurentii atcc® 18803¿ for both batches tested from 24h incubation of strips.Finally, the investigator did not observe any visual defects for the three (3) strips tested for the batch 1008311320.Conclusion: biomérieux investigators did not reproduce the customer¿s reported issue.No evidence of a product malfunction nor product performance issues was found during the investigation.

• Brand Name: API 20 C AUX 25 STRIPS+25MEDIA - 20210
• Common Device Name: API 20 C AUX
• 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: 12497663
• Report Number: 9615754-2021-00255
• Device Sequence Number: 17090658
• Product Code: JXB
• UDI-Device Identifier: 03573026048082
• UDI-Public: 03573026048082
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: CL. I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 03/23/2022
• Device Model Number: 20210
• Device Catalogue Number: 20210
• Device Lot Number: 1008311320
• 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: 08/30/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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