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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 No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of a qcv-detected failure at position e1 in association with their vidas® analyzer (ref. 99735, serial (b)(4)). The customer confirmed the qcv-detected failure occurred on (b)(6) 2020, the last successful qcv test occurred on (b)(6) 2020. The customer performed a retrospective analysis for the impacted time frame. The retrospective analysis identified six (6) patient samples were tested in e1 position. Retesting of these samples found one (1) vzv igg) sample initially obtained a false negative result; the five (5) remaining samples showed no interpretation change from the initial test result. The customer confirmed the false negative vzv igg result was reported to the physician; however, 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 field service engineer (fse) visited the customer site and found the pump at section e1 was clogged. The fse performed a pump cleaner and noted debris from section e1; afterward a qcv test was performed and obtained passing results. 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
IT
Manufacturer (Section G)
BIOMERIEUX ITALIA S.P.A
via di campigliano 58 / loc. p
firenze 50012
IT 50012
Manufacturer Contact
danielle cooper
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10033584
MDR Text Key221030193
Report Number9615037-2020-00028
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 Received05/07/2020
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
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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