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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 Misdiagnosis (2159)
Event Type  Injury  
Event Description
On (b)(6) 2020, a customer in the united states notified biomérieux of a qcv detected failure which occurred at section a1 of their vidas® analyser (ref. 99735, serial (b)(4)). The customer confirmed the most recent passing qcv test occurred on (b)(6) 2020 and performed a retrospective analysis for the impacted timeframe. The retrospective analysis identified one (1) procalcitonin (pct) sample was initially underestimated. The original test result obtained was <0. 05 ng/ml, the repeat test obtained a value of > 2 ng/ml. The customer stated the underestimated result was reported to the physician, and treatment was withheld based upon the underestimated result of <0. 05 ng/ml. Treatment of the patient was adjusted after obtaining the corrected value of > 2 ng/ml. Although there is no indication or report from the laboratory that the discrepant result led to any direct negative impact to the patient's state of health, the customer confirmed treatment of the patient was delayed based upon the erroneous underestimated pct result. Biomérieux will initiate an internal investigation.
 
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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
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10105030
MDR Text Key194681391
Report Number9615037-2020-00031
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 07/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received06/12/2020
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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