MAUDE Adverse Event Report: BIOMÉRIEUX ESPAÑA CHROMID® S. AUREUS ELITE

Catalog Number 419042

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a false negative result for a (b)(6) strain on a chromid® s.Aureus elite (lot 1005950070) plate.The customer stated a specific strain of staphylococcus aureus did not grow on the chromid® s.Aureus elite plate.The strain was cultured on chromid® s.Aureus elite, chromid® (b)(6) smart, and blood agar.The s.Aureus only grew on the blood agar.The customer then performed disc testing and found the strain to be cefoxitin resistant.It was then cultured from the original sample tube to a new s.Aureus elite plate and a (b)(6) smart plate, and there was no growth on either plate.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from sweden had reported to biomérieux a false negative result for a mrsa strain on a chromid® s.Aureus elite (lot 1005950070) plate.The customer stated a specific strain of staphylococcus aureus did not grow on the chromid s.Aureus elite plate.An internal biomérieux investigation was performed using the strain submitted by the customer.At the time the clinical strain from the customer was received and inoculated for the investigation, the implicated batch of product was already expired.Therefore, different batches were tested in parallel, at different times of expiration.A total of eight batches were tested with the routine quality control (qc) strains reported in the analysis certificate and with the strain provided by the customer.After 24 hours of incubation, the growth and coloration for the five qc routine strains were perfect and within specifications, although batch is expired and equivalent between all batches tested.When the clinical strain was tested, the customer issue was confirmed.Method limitations described in the package insert specify that growth depends on the requirements of each individual microorganism, and therefore certain strains cannot develop on this media.The strain was sent to r&d to perform complementary tests.Their testing indicated that this is an atypical strain.The strain appears to be sensitive to one of the components in the media, which inhibits other bacteria not belonging to species of s.Aureus.The investigation concluded that the product was within product limitations, and there was not any quality defect.This is an atypical strain.

• Brand Name: CHROMID® S. AUREUS ELITE
• Type of Device: CHROMID® S. AUREUS ELITE
• Manufacturer (Section D): BIOMÉRIEUX ESPAÑA; isaac newton, 6; tres cantos; madrid, spain 28760 ; SP 28760
• MDR Report Key: 7162306
• MDR Text Key: 97411749
• Report Number: 3002769706-2018-00003
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• 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: 04/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2017
• Device Catalogue Number: 419042
• Device Lot Number: 1005950070
• Other Device ID Number: 03573026494445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1