MAUDE Adverse Event Report: BIOMERIEUX S.A. CHROMID® MRSA SMART AGAR

Catalog Number 413050

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in belgium notified biomérieux of obtaining an incorrect result for an atcc strain 4330 of staphylococcus aureus in association with the chromid® mrsa smart agar (reference (b)(4), lot 1007431410).The customer stated they obtained beige colonies.The package insert states the expected result for atcc strain 4330 is pink to red colonies.Though chromid® mrsa smart agar (reference (b)(4)) is not registered, marketed of distributed in the u.S., a similar product chromid® mrsa agar (reference (b)(4)) is registered in the u.S.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in belgium regarding an incorrect result for an atcc® 43300¿ strain of staphylococcus aureus in association with the chromid® mrsa smart agar (reference 413050, lot 1007431410).The customer stated they obtained beige colonies.The package insert stated the expected result for atcc 43300 is pink to red colonies.Biomérieux internal investigation was conducted.The manufacturing batch record for lot number 1007431410 was evaluated.The lot was manufactured on the 25-june-2019 and a total of (b)(4) (20 plates ea.) were released with an expiry date of 03-sep-2019.The quality control of the weight of the product conformed with specifications for the duration of the manufacturing process.Quality control tests were performed in order to release the product, the following controls were carried out: for control of the microbiological state and appearance of the product, 109 plates were incubated at 20-25°c and 108 plates were incubated at 33-37°c from 25 june 2019 to 1st july 2019.The results conformed with specifications: absence of contamination and appearance defects.Microbiological activity controls conformed with specifications for all atcc controls tested.Good growth and characteristic color was observed for s.Aureus atcc 43300 (mrsa), s.Aureus 0306055 (mrsa).Total inhibition was observed for the following strains; s.Aureus atcc 13150, s.Aureus atcc 29213, e.Cloacae atcc 13047, e.Faecalis atcc 29212, c.Albicans atcc 10231, s.Haemolyticus 1105071 and s.Hominis atcc 700236.All the quality controls conformed with specifications.Ph of the product was controlled and conformed with specifications.Lot number 1007431410, reference 413050 conformed with specifications for all quality controls tested.No nonconformities or deviations were registered on this lot number.Analysis of the retained sample: biomérieux retains samples of every lot number released to the market.Testing was performed in order to verify if the microbiological performance of the impacted lot number 1007431410 was in accordance with our quality control protocol.The impacted lot number was tested with the following atcc strains: s.Aureus atcc 43300, s.Aureus 0306055, s.Aureus atcc 13150, s.Aureus atcc 29213, e.Cloacae atcc 13047, e.Faecalis atcc 29212, c.Albicans atcc 10231, s.Haemolyticus 1105071 and s.Hominis atcc 700236.The bacteriological performance of the impacted lot conformed with specifications with notably, good growth and characteristic color for s.Aureus atcc 43300 after 17-19 hours of incubation.To verify the fertility of total and partially inhibited strains, trypcase soy agar (tsa), reference 43011, lot number 1007443000, expiry date 25-nov-2019 was also tested in parallel.All the results obtained are within specifications, with good growth for all atcc strains after 24 hours of incubation.The retained sample plates comply with expected specifications for all lot numbers tested.Complaint trend analysis: on the 10th of october 2019, a review of complaints indicated that no other complaints were registered on the impacted lot number 1007431410.Conclusion: the investigation did not reproduce the behavior observed by the customer.As the performance of the lot is within specifications and as our investigation did not reproduce the issue, it was determined the chromid mrsa smart agar (ref.413050, lot 1007431410) is performing as intended.

• Brand Name: CHROMID® MRSA SMART AGAR
• Type of Device: CHROMID® MRSA SMART AGAR
• Manufacturer (Section D): BIOMERIEUX S.A.; 5 rue des aqueducs; craponne, 69290 ; FR 69290
• MDR Report Key: 9076457
• MDR Text Key: 190998136
• Report Number: 9615755-2019-00007
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2019
• Device Catalogue Number: 413050
• Device Lot Number: 1007431410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1