MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS® ANALYZER

Catalog Number 99735

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomerieux to report discrepant pct assay results in association with section a-1 of the vidas analyzer.The customer indicated that qcv has passed for section a-1.The results were provided to the treating physician(s).The customer stated the discrepant results did not impact patient treatment or health."patient treatment was not adversely affected by the reporting of the original value obtained from samples run in a-1." the customer stated they noticed a shift in results a couple days prior to reporting the issue to biomerieux.The customer repeated testing of some recent patient samples (processed in section a-1) in different instrument sections; the subsequent results were dramatically different from the initial results.The customer indicated a delay of 15 - 87 hours reporting correct results.The local field service engineer (fse) visited the customer site to investigate the reported issue.The fse determined the pump for section a-1 was clogged.The fse cleaned the pump and performed leak tests to confirm issue resolution.The instrument was returned to the user for routine use.Local investigation concluded the issue was the result of a clogged pump.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in the united states contacted biomérieux to report discrepant pct assay results in association with section a-1 of the vidas analyze (s/n (b)(4)).An internal biomérieux investigation was performed.Following this inconsistency, the customer performed a qcv on the vidas analyser s/n (b)(4), which passed on all sections of the instrument.In fact, as detailed in the retrospective analysis file sent by the customer, on (b)(6) 2016, one control (c1) run in section a-1 gave result of 3,44 (error "control out of range") at 9:46, the same control run in section a-1 gave result of 11,24 (error "control out of range") at 10:45.Then, the customer disabled the section a of the instrument.Procedure followed at the customer site: the local field service engineer (fse) visited the customer site on 11 aug 2016 to investigate the reported issue.As indicated in the complaint description, after reporting the discrepant results, the customer performed a qcv in the instrument and all results were conform.The fse checked the problem on the pump in the section a of the instrument, repaired and qualified the instrument.After the reparation and the qualification, he followed an internal checklist.Root cause: the root cause of the discrepant results in slot 1 of the section a was the pump tube, which was partially clogged.Reparation-qualification of the instrument: the biomérieux fse fixed the issue at the customer site by cleaning the pump in section a with the pump cleaner.After the reparation, the fse qualified the instrument by performing a complete leak test on the section a of the instrument.This leak test was conformed.Retrospective analysis: the retrospective analysis was done by the customer.The customer performed the tests from the slot 1 in the section a and in other slots in the other sections of the same instrument.The results of four (4) tests were different.The first results of these tests had been transmitted to the treating physicians but, according to the customer, patient treatment was not adversely affected by the reporting of the original value obtained from samples run in a-1.Conclusion: the root cause of the problem has been clearly identified by the investigation of the biomerieux fse at the customer site.The slot 1 of the section a of the instrument was partially clogged.As a partial clog can react as a leakage in a pump tube, the qcv performed by the customer did not highlight the problem.A partial clog can be highlighted by others mean like the preventive maintenance if the clog is significant enough to have an impact on results, controls performed before each run, and history of the instrument.In this case, the clog in the pump was highlighted by the controls performed two (2) times on slot a1, which were out of range (the 2 control values were completely different one relative to the other).Moreover, several interventions were done to remove clogs on this instrument since the installation ((b)(6) 2014, (b)(6) 2015, (b)(6) 2016).This is a recurrent situation.As a reminder, customer must use the instrument with good quality sample.The instrument has been repaired cleaning the section a pump tubes with the pump cleaner and then the instrument was qualified by performing a leak test.After fse intervention, instrument was qualified and operational.

• 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: 5910074
• MDR Text Key: 53327742
• Report Number: 3002769706-2016-00156
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99735
• Device Lot Number: IVD3004813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• 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