Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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(TM) MRSA
  • 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(TM) MRSA Back to Search Results
Catalog Number 43451
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 (b)(6) reported a problem of growing strain staph aureus when using chromid(tm) (b)(6) plate; ref.43451, lot 1004166650, expiry date; 10/02/2015.The strains do not have the gene (b)(6) and no plp2a.The lack of growth led to (b)(6) results when using the chromid(tm) (b)(6) product.There was no reported impacted to the patient as a result of the discrepant result.An investigation will be initiated by biomerieux.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHROMID(TM) MRSA
Type of Device
CHROMID(TM) MRSA
Manufacturer (Section D)
BIOMÉRIEUX SA
5, rue des aqueducs
craponne, fr 69290
FR  69290
Manufacturer (Section G)
BIOMÉRIEUX SA
5, rue des aqueducs
craponne, fr 69290
FR   69290
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5318136
MDR Text Key34154090
Report Number3002769706-2015-00175
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K091024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/02/2015
Device Catalogue Number43451
Device Lot Number1004166650
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-