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
A customer in the (b)(6) notified biomérieux of a qcv detected failure occurring at section a1 of the vidas® analyzer (ref.99735, serial number (b)(4)).The customer confirmed the last passing qcv test was performed on (b)(4) 2020.A retrospective analysis was performed for the impacted timeframe.The retrospective analysis identified thirty-five (35) procalcitonin and d-dimer samples were tested at position a1 during the impacted timeframe.Eight (8) samples were unable repeated.All other samples from the impacted time period were retested.The following three resulted in an interpretation change.Sample 1 d-dimer original result = 280.94 ng/ml - negative, sample 1 d-dimer repeat result = 726 ng/ml ¿ positive.Sample 2 pct original result = 0.11 ng/ml, sample 2 pct repeat result = 0.53 ng/ml.Sample 3 pct original result = <0.05 ng/ml, sample 3 pct repeat result = 0.75 ng/ml.The customer confirmed the initial results were reported to the treating physician; however, there is no indication or report from the laboratory that the discrepant results led to any adverse event related any patient's state of health.A biomérieux field service engineer (fse) visited the customer site and obtained a failing qcv result for section a1.The fse then performed a pump cleaner, and replaced the door plunger and seals.The instrument is now operational.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of a qcv detected failure occurring at section e1 of the vidas® analyzer (ref.99735, serial number (b)(6)).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 analyser additional information was obtained from the field service engineer (fse) that performed the on-site testing and maintenance.The fse performed a pump test for position e1 and the test failed.The fse reported that the pump channel for e1 was visibly clogged.The fse performed a pump cleaning on section e1, which cleared the clog and the instrument was returned to normal functionality.A final leak test was performed in order to quality the instrument and all values were within expected range.The initial report incorrectly stated that the affected position was a1.The correct information is that the affected position was e1.

• 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: 9910627
• Report Number: 9615037-2020-00022
• Device Sequence Number: 11621900
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/27/2020

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: 03/05/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1