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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of a qcv failure occurring in position b1 when using the vidas® analyser instrument (ref. 99735, serial (b)(4)). The retrospective analysis performed showed an impact on vidas® b·r·a·h·m·s pct¿ (procalcitonin) test results. This qcv failure occurred on (b)(6) 2020. Fse intervention was performed on (b)(6) 2020, and the issue was resolved by a seal replacement. The last conforming qcv was performed on (b)(6) 2020. Qcv failure is not a malfunction; however, it can be associated with incorrect results (prior to qcv failure). Therefore, biomérieux requests customers to conduct a retrospective analysis from the last passed qcv until the present qcv failure. The customer performed a retrospective analysis for samples run in position b1 of the vidas analyser from the (b)(6). During the concerned period of time, for vidas pct, 72 samples were run in position b1. It was indicated that only 26 of these samples were reran in retrospective analysis (other samples were not available). For these 26 samples, the retrospective review determined that three (3) samples had initial underestimated results regardless of the range of expected values for the different indications for use for the vidas pct assay (sepsis or ltri). There is no indication or report from the laboratory that the discrepant results led to any incorrect treatment or any adverse event related to any patient's state of health. A biomérieux internal investigation will be 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
firenze 50012
IT 50012
Manufacturer (Section G)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
firenze 50012
IT 50012
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key11097726
MDR Text Key250338513
Report Number9615037-2020-00039
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 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
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 Received01/19/2021
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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