MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID(TM) MRSA 20 PLT

Catalog Number 43451

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer called to report a (b)(6) result when using chromid mrsa plate, (b)(4), lot 1004200300.Patient sample was from a permanent catheter, can mixed media culture (b)(6), isolated using chromid mrsa , growth after 24 hours incubation.Customer repeated test two times using vitek 2 results were (b)(6) both times.Customer reports there was a delay in reporting results, no patient harm reported.

• Brand Name: CHROMID(TM) MRSA 20 PLT
• Type of Device: CHROMID(TM) MRSA 20 PLT
• 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: 5225387
• MDR Text Key: 31336617
• Report Number: 3002769706-2015-00144
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/04/2015

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: 10/20/2015
• Device Catalogue Number: 43451
• Device Lot Number: 1004200300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1