MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA 100 PLT - 43459; CHROMID¿ MRSA 100 PLT - 43459

Catalog Number 43459

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 client from (b)(6) notified biom¿rieux that he obtained blue colonies on chromid (b)(6) 100 plt (ref.43459), indicating a (b)(6) strain.The client performed vitek¿ 2 ast analysis using colonies from the chromid (b)(6) and obtained cefoxitin screen positive and (b)(6) mic modified to resistant ((b)(6)).Upon repeat of the vitek 2 ast, results were (b)(6) and cefoxitin screen negative ((b)(6)).The initial vitek 2 result (potential (b)(6)) is documented in (b)(4).Alternative test methods were performed.(b)(6).Following multiple requests, the customer has not provided detail regarding pre-analytical setup techniques.There is no information indicating any harm to patient resulting from this discrepancy.

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 unknown).The customer observed yellow colonies for all five separate isolates, and stated the expected colony color was green indicating a positive mrsa result.As no product lot number nor strain was provided for investigation, it was not possible to perform testing to confirm the customer's results.The global trending performed on the chromid mrsa agar, references 43451/43459, showed a very low number of complaints.No product performance issue was highlighted during the analyzed period.As the impacted lot number was unknown, testing could not have been carried out on associated retained kits during the investigation.It is possible that the patient strain that showed green characteristic colonies on the mrsa agar was not a carrier of the gene meca as described in the limitations of the product: "certain strains of s.Aureus which do not have the meca gene may develop typical colonies on this type of medium after 24 or 48 hours of incubation." another potential explanation is that the strain is a carrier of meca gene but lowly expressed, or carrier of mecc gene.Another potential root cause for this issue is the storage and handling of the product.Chromogenic media are very sensitive to light and this could impact the results.Complaints will continue to be monitored on these references.

• Brand Name: CHROMID MRSA 100 PLT - 43459
• Type of Device: CHROMID¿ MRSA 100 PLT - 43459
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11087548
• MDR Text Key: 251613187
• Report Number: 9615755-2020-00034
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1