MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA S. AUREUS AGAR; CHROMID® MRSA S. AUREUS AGAR

Catalog Number 43466

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

Note: reference 43466 is not registered in the united states.The u.S.Similar device is product reference 414524.A customer from switzerland notified biomérieux of discrepant colony color while culturing five (5) staphylococcus aureus isolates from four (4) separate patients using chromid® (b)(6) s.Aureus (ref.43466, lot 1008025430).The customer observed yellow colonies for all five separate isolates, and stated the expected colony color was green indicating a positive (b)(6) result.The isolates were tested using the vitek® 2, agglutination test, and pcr test methods; all tests results were mrsa positive.The chromid® (b)(6) s.Aureus agar instruction for use (ifu) results and interpretation section states the presence of at least one (1) green colony gives the sample a positive (b)(6) status.There is no indication or report from the laboratory that the discrepant results led to any adverse event related any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in switzerland regarding discrepant colony color while culturing five (5) staphylococcus aureus isolates from four (4) separate patients using chromid® mrsa s.Aureus (ref.43466, lot 1008025430).The customer observed yellow colonies for all five separate isolates, and stated the expected colony color was green indicating a positive mrsa result.An internal investigation was conducted using biomerieux retained samples of the subject lot, and on the plates received from the customer.The testing results confirmed the product performed within expected specifications.All the quality control tests (macroscopic appearance, ph measures and microbiological performance) carried out prior to releasing this lot were within specifications.The customer issue was not reproduced through the internal investigation performed on the retain samples, nor with the customers plates provided.A root cause of the event could not be established.See section h10.

• Brand Name: CHROMID MRSA S. AUREUS AGAR
• Type of Device: CHROMID® MRSA S. AUREUS AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 10226703
• MDR Text Key: 225940782
• Report Number: 9615755-2020-00011
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1