MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS ANALYZER

Model Number 99735

Device Problems Complete Blockage (1094); Occlusion Within Device (1423); Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the (b)(6) contacted biomerieux to report a qcv (quality control verification) failure (position a1) in association with the vidas analyzer.The customer was advised to take the section offline until service could be obtained.The local field service engineer (fse) visited the customer site to evaluate the vidas issue.The fse cleaned the pump for section a-1.Subsequent qcv testing and pump tests pass.The reported issue was resolved.As the same discrepancy could have occurred with a patient sample since the last successful qcv ((b)(6) 2016), the customer was instructed to conduct a retrospective analysis.Retrospective analysis by the customer determined a total of eight (8) incorrect patient results had been reported since the last successful qcv; seven (7) were confirmed to have had no adverse impact to the patient's state of health, one result is awaiting confirmation by the clinical scientist.The customer reports a delay of up to six (6) days to obtain the correct results following pump cleaning by the fse.There is no indication or report from the laboratory that the failed qcv and subsequent retrospective analysis identified any adverse event related to any patient's state of health.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in the (b)(6) contacted biomérieux to report a qcv (quality control verification) failure (position a1) in association with the vidas® analyzer.An internal biomérieux investigation was performed.The customer reported a very low value tv1 of 1.00 instead of greater than 5.5 for position a1 during the quality control verification (qcv) testing.The customer reported also that external positive controls failed four (4) times on the same position in the instrument.The last conform qcv was performed on (b)(6) 2016.As requested by biomérieux, the customer stopped using the section a of the instrument and performed a retrospective analysis between the last conform qcv ((b)(6) 2016) and the failed qcv (02aug2016).Retrospective analysis performed on the position a1 during the relevant period determined eight (8) patient samples may have been affected.Root cause: the qcv failure detected in the section a slot 1 highlighted a possible clog issue in this position.Observation of a qcv failure is not an abnormal behavior.It means that the qcv performed its functional control, which 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 conformed, it can be determined that a clog is present in the pump of the section a slot 1.Therefore, the root cause was determined to be a clog in the slot 1 of the pump in the section a.As the clog was confirmed, the field service engineer (fse) cleaned the six (6) slots of the section a pump with the pump cleaner and noticed some dust during drilling of the pump at position 1 (which confirmed again the clog issue).After the cleaning, the fse performed a new pump tester on the section a.This time, the results in all slots of the section a were conform indicating the pump issue was resolved and the instrument repaired.After the repair, the fse qualified the instrument by performing two (2) new qcvs on section a of the instrument.Both qcv results were conform.Retrospective analysis: as requested by biomérieux, the customer performed a retrospective analysis for tests that had been performed on the slot 1 of the section a of the instrument from the (b)(6) 2016 (date of the last conform qcv) to the (b)(6) 2016 (date of this qcv failure).The retrospective analysis showed that eight (8) patient samples, which had been run on section a slot 1, could have been affected for vidas® vzg assay, msg assay, hcv assay and txc assay.As detailed in the retrospective analysis document, for the eight (8) patient samples, there were no consequence on the treatment (inappropriate or delayed treatment) and no clinical consequences due to false results (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: 5912447
• MDR Text Key: 53446714
• Report Number: 3002769706-2016-00159
• Device Sequence Number: 1
• Product Code: DEW
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

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 Model Number: 99735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2016
• 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: Initial
• Patient Sequence Number: 1