MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID[TM] MRSA

Catalog Number 43451

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On (b)(6) 2015, a customer in (b)(6) reported a mis-identification associated with chromid[tm] (b)(6) smart plate.The main sample reading time was 48h with reports of green colonies.There was no report of impact to the patient or patient treatment, but there was a delay in reporting results.

• 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: 5294342
• MDR Text Key: 33435884
• Report Number: 3002769706-2015-00170
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 11/17/2015

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 Catalogue Number: 43451
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/14/2015
• 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