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Model Number 410417
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
Event Description
A customer in (b)(6) contacted biomérieux to report a qcv (quality control verification) failure (section a1) in association with the vidas analyzer. The qcv was performed in response to physicians stating unexpected tnsh results were reported for patients. The local field service engineer (fse) visited the customer site and performed service in the way of pump cleaning and seal replacement. The failure continued to occur; replacement pump was necessary. Following pump replacement, the qcv test passes. All other sections were also confirmed to be functioning properly. Biomérieux advised the customer to perform a retrospective analysis to the last successful qcv test. The customer stated there has been no impact to patient treatment. There is no indication or report from the laboratory that the failed qcv and/or recommended retrospective analysis identified any adverse event related to any patient's state of health. Biomérieux investigation will be initiated.
Manufacturer Narrative
A customer in (b)(6) contacted biomérieux to report a qcv (quality control verification) failure in association with the vidas® analyzer. An internal biomérieux investigation was performed. The customer reported to biomérieux that unexpected tnsh results were reported for patients by the physician and tnsh calibration value was out of range in slot a1 with vidas® analyzer eu (s/n: (b)(4)). The field service engineer (fse) confirmed the problem by performing a qcv three (3) times, which showed a very low value tv1 all three (3) times. The last conform qcv was performed on this instrument on 24jun2016. The last preventive maintenance was performed on this instrument on 09jun2016. After the qcv failure, the customer stopped using the section a of the instrument and performed a retrospective analysis between the last conform qcv (24jun2016) and the failed one (15jul2016). Retrospective analysis performed on the position a1 during the relevant period determined two (20 patient samples may have been affected (note: one sample tested twice). Root cause: the qcv failure detected in section a slot 1 highlighted a possible clog issue in this position. Observation of a qcv failure is not an abnormal behavior but means the qcv performed as a functional control. This control is meant to detect residual risks, that are rare and sudden. Those risks are already present and accepted into the vidas® systems risk analysis. The vidas® pump tester is used to validate or invalidate the presence of a clog in the pump tested. As the result value of the vidas® pump tester in section a slot 1 was not conform, the root cause was determined to be a clog in the slot 1 of the pump in section a. Reparation - qualification of the instrument: as the clog was confirmed, the fse cleaned the six (6) slots of the section a pump with the pump cleaner and replaced the dirty seals. After the cleaning, the fse performed a new pump tester on the section a. The result value in the section a slot 1 was still not conform; therefore, the fse then replaced the section a pump assembly and performed all needed adjustments. After the replacement, the fse qualified the instrument by performing a leak test on the section a of the instrument. The result values of the leak test were conform for the six (6) slots of section a. The instrument was qualified by performing a leak test at the end of the intervention and result values were all conform on all slots of section a retrospective analysis: as requested by biomérieux, the customer performed a retrospective analysis for tests that were performed on slot 1 of section a of the instrument from the 24jun2016 (date of the last conform qcv) to 15jul2016 (date of the qcv failure). The retrospective analysis showed that two (2) patient samples that were run on section a slot 1 were affected (note: one sample tested twice). As detailed in the retrospective analysis document, for the two (2) patient samples, there was no consequence on the treatment (inappropriate or delayed treatment) and no clinical consequences due to false result (e. G. Hospitalization, delayed or wrong diagnosis, death or injury).
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Manufacturer (Section D)
via di campigliano 58
ponte-a ema
firenze, italy 50015
IT 50015
Manufacturer (Section G)
via di campigliano 58
ponte-a ema
firenze, italy 50015
IT 50015
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
MDR Report Key5950881
MDR Text Key54766209
Report Number3002769706-2016-00254
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410417
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 Received07/15/2016
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