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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER

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BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER 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 Date 10/22/2019
Event Type  malfunction  
Event Description
A customer in the united states notified biomérieux of a qcv failure in section b1 of the vidas instrument (ref. 99735, s/n (b)(4)). The customer stated the last successful qcv was performed on (b)(6) 2019. Retrospective analysis to this date identified six (6) patient tests were processed in section b1. The initial and repeat tests of four (4) patients matched; no change in interpretation. Two (2) patient results (procalcitonin, pct) were potentially impacted by the section b1 issue. - patient 1 (fda medwatch 9615037-2019-00031): the initial result of one sample was <0. 05; when repeated in section a the result was 27. Another pct test performed two (2) days later gave a result of 17. This patient was already on vancomycin. - patient 2 (fda medwatch 9615037-2019-00032): the initial result of one sample was 0. 09; when repeated in section a the result was 0. 7. Both patients are hospital inpatients. The initial results were reported to the physician. The customer stated they have no information regarding any adverse impact to patient. The customer indicated they perform vidas cleaning with tergazyme and 10% bleach diluted with deionized water. The recommended cleaning agents are alconox or liquinox. Biomérieux internal investigation will be conducted.
 
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Brand NameVIDAS® ANALYZER
Type of DeviceVIDAS® ANALYZER
Manufacturer (Section D)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
50012 bagno a ripoli
firenze,
IT
Manufacturer (Section G)
BIOMERIEUX ITALIA S.P.A.
via di campigliano 58 / loc. p
50012 bagno a ripoli
firenze,
IT
Manufacturer Contact
jennifer armstrong
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9353434
MDR Text Key219571374
Report Number9615037-2019-00031
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 01/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2019
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 Received12/13/2019
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 Unkown

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