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

Catalog Number 413050

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 manufacture.

Event Description

On (b)(6) 2015 a customer in (b)(6) reported to biomerieux a false susceptible results when using chromid mrsa smart 20 plates.The customer stated product was used prior to expiration date.Customer was testing a patient rectal specimen, which was known to be (b)(6).The chromid mrsa smart plate did not grow with suspect colonies.When using a different media (b)(6) (bd), results indicated (b)(6).Customer did not report any patient harm or delay in reporting results.

Manufacturer Narrative

Biomerieux performed and investigation into a (b)(6) clinical strain (rectal sample) when using a chromid mrsa smart kit.The customer reported that the coloration was not specific, white colonies observed, and only small colonies were observed after 16 and 40 hours.The temperature of incubation was 37°c.Confirmation of the strain was performed.The customer did not return the strain in question; therefore, testing was unable to be performed to confirm the customer's issue.The batch production records were reviewed and no related anomalies were noted.A trend review was performed for this lot and no other related complaints were found.A review of the package insert versus the customer procedure was performed.The customer used a rectal swab sample and read the results at 16 and 40 hours.Per the package insert the results should be read between 18 and 24 hours after incubation is started; therefore the customer did not perform either reading within the recommended reading window.Additionally, a rectal swab sample is not an approved source of organism for the chromid mrsa smart kit.The issue reported by the customer could not be confirmed.

• Brand Name: CHROMID(TM) MRSA SMART PLATES
• Type of Device: CHROMID(TM) MRSA SMART PLATES
• 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: 5240230
• MDR Text Key: 31767462
• Report Number: 3002769706-2015-00151
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• 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: 10/21/2015
• Device Catalogue Number: 413050
• Device Lot Number: 1004218520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1