MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA

Catalog Number 43451

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 in (b)(6) reported to biomérieux an increase in (b)(6) results in association with chromid® mrsa.Initially, the customer reported the issue involved chromid® mrsa smart; however, on (b)(6) 2017, the customer reported the product as chromid® mrsa (lot 1005201380).The customer reported the chromid® mrsa is mostly used for screening nose and throat cultures, and that detection of a (b)(6) is confirmed by maldi-tof and vitek® 2 ast testing.The customer stated they have recently noticed a decrease in the false positive rate.The customer reported that results were impacted and there has been error in patient treatment along with a delay for reporting results.There is no indication or report from the hospital or treating physician to biomérieux that discrepant results led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) reported an increase in (b)(6) results in association with (b)(6).An internal biomérieux investigation was performed.The investigation consisted of a review of complaints registered for the impacted lot numbers, a file review of the impacted lot numbers and analyses of the retained sample plates for the impacted lot numbers within the expiry date.A review of complaints recorded for the five (5) impacted lot numbers indicated that no other complaints were registered apart from the complaint in question.A file review of the impacted lot numbers indicated all of the plates conformed with specifications; neither contamination nor defects in appearance were detected.For all the lot numbers reviewed: - the quality control of the weight of the product conformed with specifications for the duration of the manufacturing process.- the quality control certificate conformed with specifications for the product's appearance, colour, ph, microbiological activity and microbiological state.- the technical laboratory quality controls indicated that the quality controls conformed with microbiological activity specifications.The following controls were tested; staphylococcus aureus atcc 43300 bmr, staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231, enterococcus faecalis atcc 29212, staphylococcus aureus 05-04-605, staphylococcus aureus 05-06-614, enterococcus faecalis atcc 29212, staphylococcus aureus atcc 43300 bmr.- no non-conformances nor deviations were detected for any of the lot numbers.Analyses of the retained sample plates indicated the following: - quality control strains were tested on one (1) of the impacted lot numbers, 1005990890, and a reference lot number, 1006038200 (exp 04-jan-2018).- the following controls were tested: staphylococcus aureus atcc 43300 bmr, staphylococcus aureus atcc 29213, escherichia coli atcc 8739, candida albicans atcc 10231, enterococcus faecalis atcc 29212, staphylococcus aureus 05-04-605, staphylococcus aureus 05-06-614, enterococcus faecalis atcc 29212, and staphylococcus aureus atcc 43300 bmr.- the test results indicated that the quality controls conformed with microbiological activity specifications for both lots tested.- the testing performed did not reproduce the issue observed by the customer.As the patient strains in question were not returned by the customer, further investigations could not be pursued.Of note, the package insert states in the reading and interpretation section "a.Direct inoculation · after 18-24 hours of incubation, for nose specimens, a green color is characteristic of mrsa.For the other types of specimens the typical colonies must be identified using biochemical or immunological tests (s.Aureus).If identification of s.Aureus is confirmed, check the resistance of the strain to methicillin.· after 48 hours of incubation and whatever the type of specimen, the typical colonies should be identified following the same procedure." the investigation concluded the chromid® mrsa agar is performing as intended.

• Brand Name: CHROMID® MRSA
• Type of Device: CHROMID® MRSA
• Manufacturer (Section D): BIOMÉRIEUX SA; 5, rue des aqueducs; craponne, fr 69290 ; FR 69290
• MDR Report Key: 7031249
• MDR Text Key: 93167887
• Report Number: 3002769706-2017-00364
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2016
• Device Catalogue Number: 43451
• Device Lot Number: 1005201380
• Other Device ID Number: 03573026136642
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1