MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS® ANALYZER

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).

• Brand Name: VIDAS® ANALYZER
• Type of Device: VIDAS® ANALYZER
• Manufacturer (Section D): BIOMÉRIEUX ITALIA; via di campigliano 58; ponte-a ema; firenze, italy 50015 ; IT 50015
• Manufacturer (Section G): BIOMÉRIEUX ITALIA; via di campigliano 58; ponte-a ema; firenze, italy 50015 ; IT 50015
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5950881
• MDR Text Key: 54766209
• Report Number: 3002769706-2016-00254
• Device Sequence Number: 1
• Product Code: DEW
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• 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: N
• Patient Sequence Number: 1