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

Model Number 410417

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 (b)(6) contacted biomérieux to report a qcv-detected failure in section c1 of the vidas® instrument (reference 410417, serial (b)(4)) using qcv lot 200326-0. The qcv-detected failure occurred on (b)(6) 2019; the most recent successful qcv occurred (b)(6) 2019. The customer performed a retrospective analysis for this affected timeframe. Review of the initial and re-test results submitted by the customer determined one false (b)(6) result was obtained but not reported to the treating physician. The customer did confirm there was a one day delay in reporting due to retesting from a new collection and testing in another section. 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. A biomérieux internal investigation will be conducted.

• Brand Name: VIDAS® ANALYZER
• Type of Device: VIDAS® 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 Key: 8866734
• MDR Text Key: 188863291
• Report Number: 9615037-2019-00013
• Device Sequence Number: 0
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 08/06/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 410417
• 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 Received: 10/21/2019
• 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