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

Model Number	99735
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in finland notified biomérieux of an instance where the customer's vidas® analyzer (ref 99735, serial (b)(4)) stopped running while processing external quality control samples.The customer reported that the issue occurred one (1) time and all segments of the instrument were affected.The instrument did not generate any error messages.The customer confirmed that there were no patient samples being processed at this time, but results for the external quality control samples were delayed due to having to prepare new strips and re-run tests.The following tests were being performed when the vidas® analyzer stopped running: ref.(b)(4) vidas® hiv duo ultra (3 samples) ref.(b)(4) vidas® hbc igm ii (3 samples), ref.(b)(4) vidas® hbs ag ultra (3 samples), ref.(b)(4) vidas® anti-hbc total ii (3 samples).The customer restarted the instrument and this corrected the issue.A preliminary investigation performed by global customer service (gcs) identified that there were multiple instances of the instrument resetting while the tests were being performed, however the cause for the resets has not been identified at this time.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in finland regarding vidas® analyzer (ref 99735, serial (b)(6)) stopped running while processing external quality control samples.The customer reported that the issue occurred one (1) time and all segments of the instrument were affected.The instrument did not generate any error messages.An internal investigation was conducted analyzing the instruments log files to determine if there was an issue during the run.A field service engineer (fse) was also sent to the customer site.On-site log review by the fse revealed there were multiple instrument resets that occurred during the run which is considered abnormal behavior.The cause of this event is an instrument reset during the testing.The root cause for the reset is unknown.Possible causes of the reset are: failure of ups, bad connection or operator error, or failure of instrument power supply.The customer was recommended to change the power supply of the instrument and/or the ups, should the issue recur.

• Brand Name: VIDAS ANALYSER
• Common Device Name: VIDAS® ANALYSER
• Manufacturer (Section D): BIOMERIEUX ITALIA S.P.A.; via di campigliano 58 / loc. p; 50012 bagno a ripoli; firenze ; IT
• MDR Report Key: 10220850
• Report Number: 9615037-2020-00034
• Device Sequence Number: 19500281
• Product Code: DEW
• UDI-Device Identifier: 03573026140427
• UDI-Public: 03573026140427
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K891385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 06/01/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1