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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 Resultor 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.
 
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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
tenika rhodes
100 rodolphe street
durham, NC 27712
3145068201
MDR Report Key10020177
MDR Text Key209193219
Report Number9615037-2020-00026
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 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2020
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 Received05/18/2020
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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