MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS® ANALYZER

Model Number W3205

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 from the (b)(6) reported to biomérieux a qcv failure in association with the vidas® analyzer.The customer reported false negative results due to a failed qcv ,at pump r1, 2 & 3 due to the pump not drawing or dispensing liquid.The customer analyzed results obtained after the previous qcv and retested samples.Several false negative results were identified which included tests for cmvg (cytomegalovirus) and ebna (epstein barr nuclear antigen).There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the (b)(6) reported to biomérieux a qcv failure in association with the vidas® analyzer.An investigation was performed.On (b)(6) 2017, a biomérieux field service engineer (fse) visited the customer site.The fse performed a pump test on section b.Of the instrument and noticed that position b1 was completely blocked: b1 value was at 0.The fse changed the pump/actuator and seals.The pump test was performed again, and all results were conforming: values were between 198 and 229 (the expected value is greater than 140).A qcv test was then performed which qualified the instrument, and confirmed b1 position was conforming.The root cause was a clog in b1 position, detected by qcv failure on (b)(6) 2017.A retrospective analysis was performed between the last good qcv (b)(6) 2017 and the solving qcv issue (b)(6) 2017.The retrospective analysis showed that 48 samples were run in the position b1: 12 cmv igg, 22 cmv igm, 5 rubella igm, 6 ebv nuclear igg, 1 vzv igg, 1 ebv capsid igg and 1 ebv capsid igm.Ten results showed a change in the result, including nine reported to the physician.The customer has provided the following results: (b)(6).The clinical implications were as follows: ebv: three were incorrect ebv nucleic acid tests which then led to performing additional tests (heterophile, ebv capsid igg and ebv capsid igm).For ebv markers such as ebv capsid (vcam and vcag) and ebv nucleic (such as ebna), as it is mentioned in the package insert of the these three vidas assays.The interpretation is based on the results of the three markers.In case of an equivocal result determined by the three markers, it is necessary to repeat analysis.For ebv customer testing, ebna igg fis tested irst and followed up with heterophile if the nuclear igg is negative.If it is negative then they test ebv and capsid igg and igm.All three of the cases were ebv capsid igg positive thus indicating past infection.One of the affected patients was being worked up for a renal transplant.For this patient, the renal transplant had a previous positive ebv although this was a while ago.The customer assumed that the nuclear igg became negative due to declining antibody titre and therefore this did not result in any inappropriate treatment.Cmv: five incorrect cmv igg results were reported.One had a strong positive cmv igm so the updated result did not changed management of the patient.The remaining four had all been reported, but have no clinical implications as none were part of a transplant work up.Vzv igg : this test had been run as an urgent sample but was not reported.Further testing showed that this patient was immune.The investigation concluded that the root cause was a clog in the b1 position of the vidas® analyzer.

• 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6774945
• MDR Text Key: 83119295
• Report Number: 3002769706-2017-00230
• Device Sequence Number: 0
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W3205
• Other Device ID Number: 03573026030292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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: N
• Patient Sequence Number: 1