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U.S. Department of Health and Human Services

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

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BIOMERIEUX ITALIA S.P.A. VIDAS ANALYSER VIDAS® ANALYSER Back to Search Results
Model Number 99735
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event 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.
 
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Brand NameVIDAS ANALYSER
Type of DeviceVIDAS® ANALYSER
Manufacturer (Section D)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
50012 bagno a ripoli
firenze
IT
Manufacturer (Section G)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
50012 bagno a ripoli
firenze 50012
IT 50012
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10220850
MDR Text Key221030207
Report Number9615037-2020-00034
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K891385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number99735
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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