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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 Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
On (b)(6)-2020, a customer from united states notified biomérieux of a qcv detected failure at positon b1 in association with the vidas® analyzer (ref.99735, serial (b)(4)).The customer stated the most recent passing qcv test was completed on (b)(6) 2020.A retrospective analysis was performed for the impacted time frame.Ten (10) procalcitonin (pct) samples from separate patients were tested in positon b1 between (b)(6) 2020 and(b)(6) 2020.Seven (7) samples were repeated, three (3) samples were not repeated.One (1) sample was initially underestimated for pct.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.A biomérieux field service engineer (fse) visited the customer site and found the pump at position b1 was clogged.The fse performed a pump cleaner then performed a leak test and qcv test; both tests passed.Biomérieux will initiate an internal investigation.
 
Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding a qcv detected failure at positon b1 in association with the vidas® analyzer (ref.99735, serial (b)(6)).Control c1 did not pass on position b1.A qcv failure is not an abnormal behavior.It means that the qcv played its role as a functional control.This control is meant to detect residual risks, that are rare and sudden.Those risks are already present and accepted into the vidas system risk analysis.A biomérieux field service engineer (fse) visited the customer site and found the pump at position b1 was clogged and that the seals were dirty on all positions.The fse performed a pump cleaner and replaced all the seals.A leak test and qcv test was then performed; both tests passed.Conclusion: the cause of the qcv alert and of the failure of the control c1 in position b1 was a clogging of section b position 1.After a pump clean on the entire section, b1 passed all tests.
 
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Brand Name
VIDAS® ANALYSER
Type of Device
VIDAS® ANALYSER
Manufacturer (Section D)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
firenze 50012
IT  50012
MDR Report Key10020177
MDR Text Key209193219
Report Number9615037-2020-00026
Device Sequence Number1
Product Code DEW
UDI-Device Identifier03573026140427
UDI-Public03573026140427
Combination Product (y/n)N
PMA/PMN Number
K891385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number99735
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2020
Initial Date FDA Received05/04/2020
Supplement Dates Manufacturer Received05/18/2020
Supplement Dates FDA Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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