• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER 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 contacted biomérieux to report a qcv-detected failure in of the vidas® analyzer (reference 99735, serial (b)(4). The qcv detected failure occurred on (b)(6) 2019 the most recent successful qcv occurred on (b)(6) 2019. A retrospective analysis was performed for the affected timeframe. The customer had performed 12 pct (procalcitonin) assays at position a1 since the last successful qcv on (b)(6) 2019. Eleven (11) of the pct samples were retested. One sample was not able to be rerun; therefore, a new sample specimen for this patient was tested. Review of the initial and re-test results submitted by the customer determined nine (9) pct samples had no interpretation change, and three (3) were falsely underestimated. A biomérieux field service engineer (fse) visited the customer and confirmed the pump at position a1 was clogged. The fse cleaned the instrument and obtained a passing qcv result. There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be conducted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIDAS® ANALYZER
Type of DeviceVIDAS® ANALYZER
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,
IT
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9221200
MDR Text Key219784210
Report Number9615037-2019-00025
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923579
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 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
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 Received12/18/2019
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 Unkown

-
-