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U.S. Department of Health and Human Services

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

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BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER Back to Search Results
Model Number 410417
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 (b)(6) contacted biomérieux to report a qcv-detected failure in section c1 of the vidas® instrument (reference 410417, serial (b)(4)) using qcv lot 200326-0. The qcv-detected failure occurred on (b)(6) 2019; the most recent successful qcv occurred (b)(6) 2019. The customer performed a retrospective analysis for this affected timeframe. Review of the initial and re-test results submitted by the customer determined one false (b)(6) result was obtained but not reported to the treating physician. The customer did confirm there was a one day delay in reporting due to retesting from a new collection and testing in another section. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be conducted.
 
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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
jennifer armstrong
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key8866734
MDR Text Key188863291
Report Number9615037-2019-00013
Device Sequence Number0
Product Code JJE
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 foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410417
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 Received10/21/2019
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

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