MAUDE Adverse Event Report: BIOMÉRIEUX ITALIA VIDAS ANALYZER

Model Number 99735

Device Problem Device Reprocessing Problem (1091)

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 united states reported qcv failure on slot in association with the vidas® analyzer ((b)(4)).The customer repeated the qcv test; the same failure occurred.The last successful qcv was performed (b)(6) 2015.The local field service engineer (fse) performed a site evaluation on (b)(6) 2015 and reported a seal required cleaning.Following fse actions, a subsequent qcv run was performed and passing results indicated the system is performing to specifications.There was no reported death or serious injury associated with the identified event.Internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was performed at the customer site by the local field service engineer (fse).The qcv failure was reproduced in section by the fse.Investigation identified debris in section.The fse removed the debris and performed qualification tests.Following repair, the qcv test passes; the section is performing in accordance with specifications.The vidas® system was returned to operation.

• 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: 5051495
• MDR Text Key: 25503650
• Report Number: 3002769706-2015-00079
• 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
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1