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

Catalog Number 43466

Device Problem 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

A customer in (b)(6) called to report when using chromi mrsa, (b)(6), (b)(4), lot.1004257280, they saw no growth.The customer stated incubation temperature was 35 degrees and incubated for 48 hours.Customer confirmed specimen strain with btb lactose agar and blood agar which identified strain as (b)(6).The chromid mrsa exhibited no growth.No patient harm was reported however, there was a delayed result.

Manufacturer Narrative

Biomerieux investigated a (b)(6) plate media.No retain testing cold be performed as the product expired on 13nov2015 prior to the investigation being started.A complaint review for this lot was performed and revealed no other similar complaints were received.Additionally, a review of the batch production records was performed and no related anomalies were discovered.No further investigation could be performed since this lot expired prior to investigation initiation.No systemic issue was found with this lot or with the product.

• 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: 5226011
• MDR Text Key: 31271124
• Report Number: 3002769706-2015-00146
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• PMA/PMN Number: K091024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Catalogue Number: 43466
• Device Lot Number: 1004257280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1