MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. VIDAS ANALYSER; 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 the (b)(6) 2019, a customer in the united states notified biomérieux of a qcv detected failure at position e1 of the vidas® analyzer (ref.99735, serial (b)(4)).The customer confirmed the last successful qcv test occurred on (b)(6) 2019; a retrospective analysis was performed for the impacted time frame.The retrospective analysis identified nine (9) procalcitonin (pct) tests were performed at section e1 using vidas® b·r·a·h·m·s pct¿ (ref.30450).Of the nine (9) impacted samples, one sample (sample 4), was initially underestimated obtaining a value of 45.82, with repeat results of >200 and 175.The initial result of 45.82 was reported to the treating physician; however, the customer confirmed there was no adverse impact to the patient.The customer confirmed the value of 45.82 has the same interpretation as the retest values of >200 and 175.All other repeated samples obtained results in agreement with the initial results, or with insignificant difference as compared to the initial results.Note: the units of measure were not reported.For sample 4, there is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Regarding all other samples, the customer confirmed there was no adverse impact related to any patient's state of health.
Additional Manufacturer Narrative
An internal investigation was initiated following the notification of a falsely underestimated vidas® procalcitonin (pct) result identified following a qcv-detected failure in section e1 of the vidas® analyzer.It should be noted 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.The local field service engineer (fse) visited the customer site to repair and qualify the instrument.The fse performed the following actions: visual inspection of the seals.Replacement of the seals.Visual inspection in the tray, on the door, on the shield insulate plate, and on the bottom of the frame.Performed a pump tester performed a pump cleaning on the sections which have ptv <140.Performed a new pump tester after the cleaning: all results passed.Free and smooth vertical movement of spr blocks checked spr block and adjusted.Checked tower height and adjusted.Checked pump block and adjusted.Checked retainer plate integrity.Checked try depth and adjusted.Performed a leak test and a qcv test to qualify the instrument.All results passed.Root cause: misalignment and a clog at position e1.The cause of the qcv failure was misalignment and a clog in position e1.The problem was solved after cleaning the pump and replacement of the seals.The system is now operating per manufacturing specifications.See section h10.

• 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: 10102174
• Report Number: 9615037-2020-00030
• Device Sequence Number: 11419386
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/14/2020

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: 99735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1