MAUDE Adverse Event Report: BIOMERIEUX SA EASYSTREAM (TM)

Catalog Number 414352

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

Summary: customer reported the easystream (tm), sn (b)(4) is not providing an indication when eluates have not been distributed correctly (not alarming).Customer reports that there has been a delay of up to 48 hours no specific details have been provided.An investigation has been initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The customer's issue was reproduced six (6) times in >3000 pipette attempts.Potential root causes, primary among them being excessive friction within the pipettor head, have been identified and analysis is being performed under corrective and preventive action (capa) record (b)(4).In the meantime, the following actions have occurred: easy stream instruments and pipettor heads in inventory at the international distribution center (idc) were returned to the supplier on (b)(4) 2015 for re-work, and subsequently received back for use on (b)(4) 2015.Product stop shipment (b)(4) was issued to subsidiaries and distributors 09 oct 2015.Biomérieux and the supplier defined a new quality control test for pipettor head performance verification.Field corrective action (b)(4) was issued to the field on 30 oct 2015 instructing replacement of the pipettor head at each customer site, using newly established quality control tests for performance confirmation.

• Brand Name: EASYSTREAM (TM)
• Type of Device: EASYSTREAM (TM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5141314
• MDR Text Key: 28571009
• Report Number: 3002769706-2015-00113
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL I, EXEMPT
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 414352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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