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U.S. Department of Health and Human Services

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

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BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYSER Back to Search Results
Model Number 99735
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of a qcv-detected failure at section a1 in association with the vidas® analyser (ref. 99735, serial number (b)(4)). The customer confirmed the qcv detected failure occurred on (b)(6) 2020 and the last successful qcv was performed on (b)(6) 2020; a retrospective analysis was completed for the impacted timeframe. The retrospective analysis showed a total of fourteen (14) vidas pct assays were performed at position a1 between 20-feb-2020 and 26-feb-2020. The customer confirmed eleven (11) samples showed no interpretation change. The retrospective analysis also found one (1) sample was initially underestimated for pct. No retest data was provided for two (2) impacted samples. The customer confirmed the discrepant result had no adverse impact to the patient¿s state of health. Biomérieux will initiate an internal investigation.
 
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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
firenze 50012
IT 50012
Manufacturer (Section G)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
firenze 50012
IT 50012
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9883214
MDR Text Key208191349
Report Number9615037-2020-00017
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K891385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
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 Received04/22/2020
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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