MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA SMART

Catalog Number 413050

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

A customer in (b)(6) reported a strain (b)(6) growth resulting in pink colonies while using the; chromid(tm) mrsa smart 20 plates.There were no reports of patient harm.

Manufacturer Narrative

An internal investigation was conducted due to the growth of colonies, with a characteristic color after 18 hours of incubation, that were identified as (b)(6) on the (b)(6), ref (b)(4), batch (b)(4) for two (2) patient samples.The first clinical strain was secretion from the bronchial tree and the second was a swab from the abdominal cavity.The customer also indicated the same result was obtained for a staphylococcus aureus atcc29213 strain.Results of the internal investigation are as follows: per identification reports, the two (2) clinical samples are strains of (b)(6).Review of complaint records - this is the first complaint for this batch number.There are no other complaints from this customer.Testing on retained samples was not possible due to the expiration of the samples upon receipt of the complaint information.In addition, it was not possible to obtain the customer strains.Batch record review: the batch (number (b)(4)) was manufactured on 25nov2015 and filled on line 2 between the hours of 1110 and 1506.A total of (b)(4) boxes were released with expiry date 03feb2016.The process parameters were in accordance with specifications.Three (3) pools of drug additives of the same batch were used.This batch was also used in other batches of finished product for which complaints have not been registered.Three (3) tanks of medium were used.No discrepancies were detected during the manufacturing or the use of the antibiotic pool.For the released batch, several qc strains ((b)(6 strains)) were tested to check the inhibition of these strains on the (b)(6).None of the qc strains, including the s.Aureus atcc 29213 strain, presented any growth after 24 hours of incubation at 33-37°c.Batch record review did not allow confirmation of the customer's issue.Since the customer's strains were not submitted, it was not possible to further investigate the discrepancy reported by the customer.Regarding the s.Aureus atcc 29213 strain, data from the customer indicated the growth of the s.Aureus strain presented as a coloration that spread over the bacterial lawn indicating the colonies were not characteristic in nature.The growth of this strain could be related to a defect in the preservation of the product.Regarding the two (2) samples of (b)(6), the package insert for (b)(6) indicates some (b)(6)strains that do not have the meca gene may produce typical colonies.The specificity of this product is (b)(4)%.In conclusion, the results of the investigation are in accordance with the performance data for the (b)(6) product.

• Brand Name: CHROMID® MRSA SMART
• Type of Device: CHROMID® MRSA SMART
• 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: 5434944
• MDR Text Key: 38228535
• Report Number: 3002769706-2016-00034
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2016
• Device Catalogue Number: 413050
• Device Lot Number: 1004471550
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1