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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX SA CHROMID(TM) MRSA SMART 20 PLATES
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BIOMÉRIEUX SA CHROMID(TM) MRSA SMART 20 PLATES Back to Search Results
Catalog Number 413050
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Not returned to manufacturer.
 
Event Description
On 07-dec-2015, a customer in (b)(6) reported a mis-identification associated with chromid(tm) (b)(6) smart plate.The initial identification was s.Lentus, however upon retest with vitek 2 the isolate was identified as enterobacter aerogenes.There was no report of impact to the patient or patient treatment, but there was a delay in reporting results.
 
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Brand Name
CHROMID(TM) MRSA SMART 20 PLATES
Type of Device
CHROMID(TM) MRSA SMART 20 PLATES
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 Key5274923
MDR Text Key32982472
Report Number3002769706-2015-00162
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeGM
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 12/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2015
Device Catalogue Number413050
Device Lot Number1004345190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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