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

Catalog Number 43841

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

On (b)(6), a customer reported discordant results when comparing the chromid(tm) (b)(6) result to another testing method (vitek 2 ast-gp67).The customer states that two chromid(tm) (b)(6) results were observed with green colonies; indication of (b)(6) the isolates were identified as staphylococcus aureus.The discrepant results from chromid(tm) (b)(6) were confirmed when compared to another test method.An investigation into the discrepant result will be initiated by biomerieux.

Manufacturer Narrative

An investigation into a misidentification event involving the chromid(tm) (b)(6) test kit.The lot number involved in the actual event was expired when biomerieux received the complaint.The customer strains were returned to biomerieux for testing.The strains were tested using a confirmatory method and was identified as (b)(6).The strains were tested on retain kits from 2 different lots that are within the expiry date, 1 at the end and one in the middle of shelf life.All testing gave the accurate result of (b)(6) at 24 hours.The batch production record of the involved lot was reviewed.No anomalies were found that could be attributed with this event.Based on the results of the investigation, the issue could not be confirmed.The product is operating as intended.

• Brand Name: CHROMID(TM) MRSA
• Type of Device: CHROMID(TM) MRSA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5318042
• MDR Text Key: 34143781
• Report Number: 3002769706-2015-00174
• 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,Followup
• Report Date: 12/15/2015

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: 11/26/2015
• Device Catalogue Number: 43841
• Device Lot Number: 1004266310
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1