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

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 customer in the (b)(6) notified biomérieux of a confirmed (b)(6) isolate that produced white colonies instead of the expected green colonies in association with the chromid¿ (b)(6) (ref 43451, lot 1008088220).Repeat analysis with lot 1008088220 also produced white colonies instead of the expected green color.The isolate was retested with a different lot of chromid¿ (b)(6) (lot 1008095130) and the expected green colonies were observed.The identification of this isolate as (b)(6) was confirmed by gram stain, latex (pro-lab, tube coagulase, and pbp2 detection), and resistance to cefoxitin.The customer confirmed that during the day the plates are located in a rack, not in the dark ¿ but not in any direct sunlight.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.A biomérieux internal investigation was completed.Lot number record analysis.All quality control tests for lot 1008088220 performed prior to release were within specifications.No performance issues were observed for this lot.(b)(6) strains tested developed spontaneous green coloration, showing expected enzymatic activity.There were no nonconformities or deviations recorded for this lot.Retained sample and returned sample/strain analysis.The customer submitted the patient isolate for investigational testing.The identification was confirmed to be (b)(6) with the vitek® 2 gp id test kit.Susceptibility testing using vitek® 2 ast cards obatined positive cefoxitin screen results, indicating a (b)(6) profile.Retains of lot 1008088220 and 1008095130 were tested in parallel using (b)(6) atcc® 43300¿ (biomérieux internal collection) as a positive quality control strain.The expected green coloration was observed for both lots.The customer's submitted strain was also tested.After 24 hours of incubation, the customer's strain of (b)(6) developed with a typical green color and equivalent growth on all lot numbers tested.Complaint trend analysis.Complaint trending was performed for lot 1008088220 and no other complaints have been registered for this lot.Final conclusion.The customer's issue was not reproduced internally.The investigation has concluded that the lot's performance is within specification and has not deteriorated since manufacture.As stated in the package insert, this media is very sensitive to light.As some plates are exposed to light for a day before use, this may be a factor linked to this issue.

• Brand Name: CHROMID MRSA AGAR
• Type of Device: CHROMID® MRSA AGAR
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10485184
• MDR Text Key: 206337098
• Report Number: 9615755-2020-00013
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Catalogue Number: 43459
• Device Lot Number: 1008088220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1