MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS D DIMER EXCLUS II 60T US; VIDAS® D DIMER EXCLUS II 60T US

Model Number	30455-01
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomerieux of obtaining underestimated results when testing an external quality control sample using their vidas® 3 instrument (ref.414356, serial number (b)(4)) and vidas® d dimer exclus ii 60t us test kit (ref.30455-01).The lot number for the assay was not provided.The customer obtained results between 1-2 standard deviations below the expected result according to qc net.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomeriuex customer service attempted to contact the customer to obtain lab reports and impacted lot numbers; to date the customer has not provided a response.It is currently unknown if the underestimated results obtained by the customer resulted in an interpretation change of the results.The customer also tested an external quality control procalcitonin sample using their vidas® 3 instrument (ref.414356, serial number (b)(4)) and obtained passing results.Biomerieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding underestimated results when testing an external quality control sample using their vidas® 3 instrument (ref.414356, serial number (b)(6) and vidas® d dimer exclus ii 60t us test kit ( ref.30455-01).The lot number for the assay was not provided.A biomérieux internal investigation has been completed with the following results: the customer was not able to provide any additional information and they could not confirm the lot number.Therefore, biomérieux chose nine (9) batches to analyze.All plasmas tested during the activity were within expected standards.According to the analysis of the quality data, no anomalies were identified during the manufacturing, control and packaging stages.A total of (b)(4) lots of control cards were analyzed and were within the expected standards and in the same trend for two (2) internal serum samples targeted at around 500 ng / ml.The cards tested were ones within expiry during the customer contact date and within expiry for one year from the customer contact date.There was no test carried out at the complaints laboratory because there was no specific lot identified by the customer and no customer sample was returned.The vidas® d dimer exclus ii batches analyzed were within the expected specifications.

• Brand Name: VIDAS D DIMER EXCLUS II 60T US
• Common Device Name: VIDAS® D DIMER EXCLUS II 60T US
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• MDR Report Key: 11181548
• Report Number: 8020790-2021-00002
• Device Sequence Number: 2270544
• Product Code: DAP
• UDI-Device Identifier: 03573026387006
• UDI-Public: 03573026387006
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K141133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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 Model Number: 30455-01
• Device Catalogue Number: 30455-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1