MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® ANALYZER

Model Number W2205

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2017

Event Type  malfunction  

Event Description

A customer in the us reported to biomérieux discrepant results associated with vidas® analyzer (reference w2205).The customer reported qcv failure with the vidas® analyzer.Biomérieux instructed the customer to rerun the qcv check and report back with the results.The customer reported a subsequent qcv failure.Biomérieux requested a retrospective data analysis be completed since the last passing qcv.The customer reported back with the data analysis results.One (1) patient was affected by the qcv failure.An initial negative mumps result was retested to be positive.The incorrect result was reported to the physician; however, the customer indicated the patient did not experience any adverse events.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

The adverse event box was inadvertently checked.This report is to correct the type of report as a product problem report.

Manufacturer Narrative

A customer in the us reported to biomérieux discrepant results due to qcv failure associated with vidas® analyzer (reference w2205).Following the calibration and qcv failures, the customer disabled section b and requested a site visit from a biomerieux field service engineer (fse).An investigation was performed.On 30mar2017, the fse performed a visual inspection of the vidas® analyzer seals and found a piece of a sample strip sticking to the rubber seal on position b1.The assumption was that debris lead to a leakage and was the cause of the calibrations and qcv failures.The fse fixed the issue by replacing the seal on position b1.The instrument was then qualified by a pump tester tool and a qcv test.The fact to observe a qcv failure is not abnormal.It means that the qcv played its role as a functional control.This control is meant to detect residual risks, that are rare and sudden, already present and accepted into the vidas® system risk analysis.Those risks are mitigated by the preventive maintenance procedure (pump tester and pump cleaner, seals replacement), and by qcv test requested to be performed each month by the customer.

• Brand Name: VIDAS® ANALYZER
• Type of Device: VIDAS® ANALYZER
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer (Section G): BIOM?RIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6529191
• MDR Text Key: 74153233
• Report Number: 3002769706-2017-00081
• Device Sequence Number: 1
• Product Code: DEW
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2205
• Device Lot Number: DASA2374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• 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: Initial
• Patient Sequence Number: 1