MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYSER

Model Number	99735
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)-2020, a customer from united states notified biomérieux of a qcv detected failure at positon b1 in association with the vidas® analyzer (ref.99735, serial (b)(4)).The customer stated the most recent passing qcv test was completed on (b)(6) 2020.A retrospective analysis was performed for the impacted time frame.Ten (10) procalcitonin (pct) samples from separate patients were tested in positon b1 between (b)(6) 2020 and(b)(6) 2020.Seven (7) samples were repeated, three (3) samples were not repeated.One (1) sample was initially underestimated for pct.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.A biomérieux field service engineer (fse) visited the customer site and found the pump at position b1 was clogged.The fse performed a pump cleaner then performed a leak test and qcv test; both tests passed.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a qcv detected failure at positon b1 in association with the vidas® analyzer (ref.99735, serial (b)(6)).Control c1 did not pass on position b1.A qcv failure is not an abnormal behavior.It means that the qcv played its role as a functional control.This control is meant to detect residual risks, that are rare and sudden.Those risks are already present and accepted into the vidas system risk analysis.A biomérieux field service engineer (fse) visited the customer site and found the pump at position b1 was clogged and that the seals were dirty on all positions.The fse performed a pump cleaner and replaced all the seals.A leak test and qcv test was then performed; both tests passed.Conclusion: the cause of the qcv alert and of the failure of the control c1 in position b1 was a clogging of section b position 1.After a pump clean on the entire section, b1 passed all tests.

• Brand Name: VIDAS® ANALYSER
• Common Device Name: VIDAS® ANALYSER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; firenze 50012 ; IT 50012
• MDR Report Key: 10020177
• Report Number: 9615037-2020-00026
• Device Sequence Number: 2812820
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K891385
• 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): 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 99735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1