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Model Number W2205R
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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.
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.
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Manufacturer (Section D)
chemin de l orme
marcy l etoile, rhone 69280
Manufacturer (Section G)
chemin de l orme
marcy l etoile, rhone 69280
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6534885
MDR Text Key201505157
Report Number3002769706-2017-00082
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberW2205R
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 Received06/27/2017
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