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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 410417
Device Problems Computer Software Problem (1112); Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
On (b)(6) 2021, a customer from (b)(6) initially reported to biomérieux that they have observed a software lockup with vidas® analyzer (ref. 410417, serial number (b)(4)), which lead to indirect harm for one patient. The customer reported that a number of samples (total of 5) were listed as completed in the software but not released in the section (result was not generated either). This issue was fixed, but one of the samples was a serum sample from a neonate which could not be re-run. This resulted in a new blood sampling from the neonate, which is being considered as an unnecessary medical procedure. A biomérieux internal investigation has been 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
dima amro
595 anglum road
hazelwood, MO 63042
MDR Report Key12675371
MDR Text Key277743480
Report Number9615037-2021-00012
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUK
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 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model 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 Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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