MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® ANALYZER

Model Number W2205R

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in the us reported to biomérieux discrepant results associated with vidas® analyzer (reference w2205r).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.Two (2) patients were reported as negative instead of positive for mumps and four (4) patients were reported as negative instead of positive for varicella.The customer reported issuing corrected results for all six (6) patients.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Customer in the us reported to biomérieux discrepant results and qcv failure in association with the vidas® analyzer (reference (b)(4)).An investigation was performed.Note: observing a qcv failure is not abnormal as the qcv is a functional control meant to detect residual risks, that are rare and sudden.These risks are already present and accepted into the vidas system risk analysis.As requested by biomérieux, the customer performed a retrospective analysis for tests which were performed on the slot 1 of the section d of the instrument.This retrospective analysis included re-running all tests which were run in slot d1 from 01mar2017 (date of the last conform qcv) to 03apr2017 (date of the qcv failure).According to the customer, the retrospective analysis showed that six (6) patient samples were affected : 2 mpg results were reported as negative instead of positive; 4 vzg results were reported as negative instead of positive.As stated by the customer, all other tests had the same result.For the six (6) false results, the customer stated that reports were corrected and that the doctors were notified.The customer confirmed that there was no consequence for the patients, no patient was harmed or treated incorrectly, and no patient was a pregnant woman, child, or immune-compromised.The investigation by the field service engineer (fse) at the customer site, identified the root cause of the qcv failure as a clog in the section d slot 1.This clog was confirmed by a result value not conforming in section d slot 1 when using the pump tester.The fse replaced the pump seals and cleaned the section d with the pump cleaner.Then the result value of the pump tester in the section d slot 1 was conforming, as the instrument was repaired.The fse performed a leak test and a qcv test and qualified the instrument.

• 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): BIOMERIEUX 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: 6534885
• MDR Text Key: 74167772
• Report Number: 3002769706-2017-00082
• 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
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2205R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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