MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA SMART AGAR

Catalog Number 413050

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the occurrence of false negative for (b)(6) atcc® 43300¿ organism in association with the chromid® mrsa smart agar.The customer stated they observed growth of white colonies rather than the characteristic red or pink of a positive reaction.There is no indication or report from the customer to biomérieux that the occurrence led to any adverse event related to any patient's state of health.There was no patient directly associated with the atcc® 43300¿ strain.Though chromid mrsa smart agar (ref.413050) is not registered, marketed of distributed in the u.S., a similar product chromid mrsa agar (ref.43841) is registered in the u.S.Strain submittal has been requested from the customer for internal biomérieux investigation.Biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported the occurrence of false negative for staphylococcus aureus (b)(6) atcc® 43300 organism in association with the chromid® (b)(6) smart agar (udi (b)(4)).An investigation was performed.The impacted lot number was expired at the time of the investigation.The manufacturing review of the lot indicated the following : one pool of (b)(6) smart additive and one pool of (b)(6) smart substrate additive were used in the manufacturing of the product.The quality control testing for the weight of the product conformed with specifications for the duration of the manufacturing process.The quality control testing for the lot conformed with specifications as indicated in the quality certificate.Staphylococcus aureus atcc 43300 and s.Aureus 0306055 were tested and the expected growth was obtained.Staphylococcus aureus atcc 13150, s.Aureus atcc 29213, e.Cloacae atcc 13047, e.Faecalis atcc 29212, candida albicans atcc 10231,s.Haemolyticus 1105071 and s.Hominis atcc 700236 were also tested with the chromid® (b)(6) smart agar and the expected total inhibition results were obtained.In conclusion, a review of the quality and manufacturing batch records confirmed the lot met specifications and did not show any evidence of the issue observed by the customer.As lot number 1005327910 expired on the 07-feb-2017, it was not possible to investigate this issue any further.

• Brand Name: CHROMID® MRSA SMART AGAR
• Type of Device: CHROMID® MRSA SMART AGAR
• 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: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6367896
• MDR Text Key: 68977533
• Report Number: 3002769706-2017-00039
• 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: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2017
• Device Catalogue Number: 413050
• Device Lot Number: 1005327910
• Other Device ID Number: 03573026390808
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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