MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID (TM) MRSA

Catalog Number 43841

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On the (b)(6) 2015, the customer called to report when using chromid(tm) (b)(6), ref.(b)(4), lot 1004229390 there was a misidentification of enterococcus and staph hominis.The customer validated multi-site samples for newborns with a combination of nasal, axilla, umbilical and rectal swabs.The customer stated incorrect results were provided and sent out >24 hours.Customer conducted additional testing identifying vancomycin sensitive e.Faecalis with a different method (details not provided).

• Brand Name: CHROMID (TM) MRSA
• Type of Device: CHROMID (TM) MRSA
• 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: 5217779
• MDR Text Key: 30995340
• Report Number: 3002769706-2015-00143
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2015
• Device Catalogue Number: 43841
• Device Lot Number: 1004229390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1