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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
Catalog Number 410417
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Issue description: on (b)(6) 2021, a customer from (b)(6) reported to biomérieux delayed result when testing patient sample with the vidas® hs troponin i 60 tests (ref. 415386, batch number not known) on the vidas analyzer (ref. 410417, serial number: (b)(4)). On daily basis, the costumer runs different parameters such as torch, tnhs, prog, ft4, ft3, (b)(6) on the vidas instrument and runs each section separately. He noticed that the result of some tests (i. E vidas® high sensitive troponin i) took a long time, more than 1 hour, to be displayed in the results menu. In addition, the user also noticed that when performing a new run on the same section, the result of the new run was displayed, while the result of the first run was not yet displayed. Last time this issue occurred on (b)(6) 2021 and the customer obtained the vidas® high sensitive troponin i result after 3 hours. There is no indication or report from the laboratory that the delayed result led to any adverse event related to patient's state of health. To be noted that the configuration of the vidas analyzer is the following: software version (b)(4), no printer connected no lis connection, ups is connected to the instrument, the pc is (b)(6). An 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 Key12487979
MDR Text Key283504581
Report Number9615037-2021-00011
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeJO
PMA/PMN Number
K891385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number410417
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 Received08/18/2021
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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