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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
A customer in the (b)(6) notified biomérieux of a qcv detected failure occurring at section a1 of the vidas® analyzer (ref. 99735, serial number (b)(4)). The customer confirmed the last passing qcv test was performed on (b)(4) 2020. A retrospective analysis was performed for the impacted timeframe. The retrospective analysis identified thirty-five (35) procalcitonin and d-dimer samples were tested at position a1 during the impacted timeframe. Eight (8) samples were unable repeated. All other samples from the impacted time period were retested. The following three resulted in an interpretation change. Sample 1 d-dimer original result
=
280. 94 ng/ml - negative, sample 1 d-dimer repeat result
=
726 ng/ml ¿ positive. Sample 2 pct original result
=
0. 11 ng/ml, sample 2 pct repeat result
=
0. 53 ng/ml. Sample 3 pct original result
=
<0. 05 ng/ml, sample 3 pct repeat result
=
0. 75 ng/ml. The customer confirmed the initial results were reported to the treating physician; however, there is no indication or report from the laboratory that the discrepant results led to any adverse event related any patient's state of health. A biomérieux field service engineer (fse) visited the customer site and obtained a failing qcv result for section a1. The fse then performed a pump cleaner, and replaced the door plunger and seals. The instrument is now operational. 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
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9910627
MDR Text Key221029480
Report Number9615037-2020-00022
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 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
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 Received04/30/2020
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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