• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID® MRSA 20 PLT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMÉRIEUX SA CHROMID® MRSA 20 PLT Back to Search Results
Catalog Number 43451
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: chromid¿ mrsa agar is a chromogenic medium for the screening of methicillin-resistant s. Aureus (mrsa) in chronic carriers or patients who are at risk for mrsa (1, 7). This medium does not replace conventional antimicrobial susceptibility tests. Mrsa are multi-resistant bacteria which may cause nosocomial infections (3, 4, 9). The detection of mrsa carriers is particularly important for the epidemiological prevention and monitoring of these infections. In this context, the use of chromid¿ mrsa agar contributes towards the active surveillance of mrsa. Description: an internal complaint was initiated following a review of a scientific publication entitled, "evaluation of different phenotypic methods to detect methicillin resistance in staphylococcus aureus isolates recovered from cyctic fibrosis patients" by garcia-caballero a, et al. This publication noted growth of methicillin susceptible staphylococcus aureus (mssa) strains on chromid mrsa agar (ref 43451). The samples tested during this study were collected from march to november 2013 as part of a national multicenter study to describe infection-colonization patterns in spanish cystic fibrosis patients. The staphylococcus aureus isolates were stored at -40° c for further studies. The authors evaluated the ability of chromid mrsa to detect methicillin resistance among s. Aureus isolates obtained from respiratory samples of cystic fibrosis (cf) patients and strains come from positive blood culture. In cf-isolates, the sensitivity was at 96. 9% but the specificity was at 73. 6% due to the unexpected grow of a high number of cf-mssa isolates (26. 4%, 33/125). The instructions for use were respected according to manufacturer guidelines. The relevance of the methodology was good with a comparison of all errors with pcr detection for mrsa strains. There is no indication from the publication that any results from the study were used for diagnosis or treatment decisions. There is no indication that any results led to any adverse event related to any patient's state of health. An investigation has been initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCHROMID® MRSA 20 PLT
Type of DeviceCHROMID® MRSA 20 PLT
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 Key12898273
MDR Text Key288624081
Report Number9615755-2021-00011
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K162076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number43451
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-