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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 High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: vidas analyzer system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). Quality control vidas® (qcv) (ref 30706): automated test for use on the vidas® system to detect abnormal operation of the vidas and mini vidas instrument pipette mechanisms and optical systems. Issue description: on (b)(6) 2021, a customer from the united states reported qcv failure when using vidas analyser ¿ ref. 99735. The first qcv failed on (b)(6) 2021 with a1 and d1 tv1 value too low. Second run a1 failed low and d1 was low but passed. Limit value
=
5. 4 first run : a1
=
1. 18 d1
=
0. 37 second run a1
=
1. 2 d1
=
5. 73. The qcv failure was confirmed on a1 and the customer had to perform a third qcv on d1. The last qcv passed on (b)(6) 2021. A field service engineer (fse) visited the customer site to inspect the instrument. Verified no change in value for affected sections a1 and d1, but possible clog. The fse used a pump cleaning tool for all sections, verified debris were cleared out from a1 and d1. Performed second pump test and verified values were showing normal pump values. Replaced with new scanner board and performed optics calibration verified normal values. Ran new leak and qcv testing, verified all values were within range. The customer performed a retrospective analysis from (b)(6) 2021 with 22 samples they tested using vidas pct ref 30450-01. Of the 22 samples, the following six samples were initially falsely overestimated: pct samples (samples, first run, retest) 2 0. 34 0. 23 interpretation change, false high 4 1. 05 0. 19 interpretation change, false high 9 0. 81 0. 05 interpretation change, false high 12 0. 42 0. 21 interpretation change, false high 16 0. 39 0. 11 interpretation change, false high 17 0. 31 <0. 05 interpretation change, false high. The customer confirmed that the discrepant results did not lead to any adverse events 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
candace martin
595 anglum road
hazelwood, MO 63042
MDR Report Key12707577
MDR Text Key281421032
Report Number9615037-2021-00016
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
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
Date Manufacturer Received11/29/2021
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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