MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID MRSA S AUREUS 20PLT US; CHROMID® MRSA S AUREUS 20PLT US

Catalog Number	414524
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide the lot number for the plates in question, and did not submit the cap survey strain for investigation.As a result, biomérieux investigation group was not able to directly test retained plate samples from the customer lot, nor confirm the cap survey strain.Of note, the issue described is within the product limitations of chromid® (b)(6) agar and noted within chromid® documentation - ¿rare (b)(6) strains may grow on chromid® (b)(6) without producing a green color at 24 hours.¿ the alpha-glucosidase activity (green coloration) of the (b)(6) could be slightly expressed if the patient is already under treatment with a strain that is more sensitive or when quality control samples are lyophilized.Another potential root cause to explain the lack of coloration is the exposure to light.The chromogenic substrate is very sensitive to light and product documentation addresses this limitation: ¿minimize exposure to light both before and during incubation, as prolonged exposure may result in reduced recovery and/or coloration of isolates.¿ as the performance for the products chromid (b)(6) agar ¿ reference 43841, and chromid (b)(6)/said agar ¿ reference 414524 remains within specifications, neither corrective nor preventive actions are required.
Event or Problem Description
A customer in the united states reported a false negative result on chromid® (b)(6).No green pigmentation of an (b)(6) strain was observed from a cap survey on the chromid (b)(6) 20 plate, reference 414524.The impacted lot number was not provided.The customer reported that no patient was impacted as the plate was used for a cap survey.Quality control testing has been performed by the customer; the results were in conformance with specifications.A biomérieux internal investigation will be initiated.

• Brand Name: CHROMID MRSA S AUREUS 20PLT US
• Common Device Name: CHROMID® MRSA S AUREUS 20PLT US
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 11386901
• Report Number: 9615755-2021-00004
• Device Sequence Number: 11802871
• Product Code: JSO
• UDI-Device Identifier: 03573026420758
• UDI-Public: 03573026420758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 414524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1