MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS ANALYZER

Catalog Number W2205

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Evaluated on-site by service engineer.

Event Description

A customer in the united states reported a qcv (quality control verification) test failure in association with the vidas system in section b, slot 4.The section was placed offline waiting for the field service engineer to resolve the issue.Samples tested in section b, slot 4 since the last successful qcv (performed (b)(6) 2015, according to the customer) were re-tested, and the customer performed a retrospective analysis.From the last successful qcv until the malfunction reported on (b)(6) 2015, five (5) tests gave a different value on retest: 2 mumps tests initially found negative gave a positive result on retest, 2 lyme tests initially found negative gave a positive result on retest, 1 cmvg test initially found negative gave a positive result on retest.The customer indicated the following initial results were reported to physician: 1 mumps test initially found negative then positive on retest, 2 lyme tests initially found negative then positive on retest, 1 cmvg test initially found negative then positive on retest.There has been no report of death or serious injury as a consequence of "slot b4" test results since the last successful qcv test was performed.There is no indication or report from the hospital or treating physician to biomerieux that the results lead to any adverse event related to the patient's state of health.A biomerieux field service engineer visited the site on (b)(6) 2015 to service the system and resolved the issue.Field service engineer evaluation: 1) performed qcv failure troubleshooting, 2) performed section b pump test - failed, 3) cleaned pump, 4) replaced solid phase receptacle (spr) seals, 5) performed qcv leak test - passed, 6) performed qcv test - passed.Post-service testing indicates system operation is normal.Cause of qcv failure in section b, slot 4 is resolved.

Manufacturer Narrative

Biomérieux investigation was conducted.Analysis of vidas® qcv results from the customer : following the observation of low concentration results on the position b04, the customer performed two successive qcv tests on 17jul15.Both qcv tests confirmed a pipetting issue (clogging or leakage) on the position b04.The most recent successful qcv on the position b04 was obtained on 01jul15.The customer follows the biomérieux receommendation of perfroming qcv on a monthly basis.The anomaly began sometime after 01jul15.Analysis of the field service engineer (fse) maintenance report for qcv out of range : the fse performed a pump test.The pump test value obtained confirmed a clogged pump channel at the b04 location.The other positions of the section are not affected.The fse cleaned the pump channel.Subsequent pump test conformed to specification.The qcv tests performed after the curative maintenance confirmed that the issue was resolved by the fse intervention.Retrospective analysis : since the last successful qcv on the position b04, five (5) patient tests provided a different value upon retest : 2 mumps tests initially found negative gave a positive result on retest: 2 lyme tests initially found negative gave a positive result on retest; 1 cmvg test initially found negative gave a positive result on retest.Based on details and statements provided by the customer, there is no evidence/indication of any impact on the patient treatment.Following fse intervention, the customer's vidas system is functioning in accordance with specifications.

• 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): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 4949771
• MDR Text Key: 24655219
• Report Number: 3002769706-2015-00059
• 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
• Remedial Action: Repair
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W2205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• 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: Reuse
• Patient Sequence Number: 1