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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
On the (b)(6) 2019, a customer in the united states notified biomérieux of a qcv detected failure at position e1 of the vidas® analyzer (ref. 99735, serial (b)(4)). The customer confirmed the last successful qcv test occurred on (b)(6) 2019; a retrospective analysis was performed for the impacted time frame. The retrospective analysis identified nine (9) procalcitonin (pct) tests were performed at section e1 using vidas® b·r·a·h·m·s pct¿ (ref. 30450). Of the nine (9) impacted samples, one sample (sample 4), was initially underestimated obtaining a value of 45. 82, with repeat results of >200 and 175. The initial result of 45. 82 was reported to the treating physician; however, the customer confirmed there was no adverse impact to the patient. The customer confirmed the value of 45. 82 has the same interpretation as the retest values of >200 and 175. All other repeated samples obtained results in agreement with the initial results, or with insignificant difference as compared to the initial results. Note: the units of measure were not reported. For sample 4, 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. Regarding all other samples, the customer confirmed there was no adverse impact related to any patient's state of health.
 
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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
jennifer armstrong
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key10102174
MDR Text Key221030200
Report Number9615037-2020-00030
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 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
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 Received06/16/2020
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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