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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID(TM) MRSA 20 PLT
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BIOMERIEUX SA CHROMID(TM) MRSA 20 PLT 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  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
On (b)(6) 2015 a customer in spain reported to biomerieux they had a (b)(6) results for ast when using, chromid mrsa 20 plates.No information was provided stating how the customer confirmed the results were incorrect.Additional information provided by the customer on (b)(6) 2015 indicated the sample was taken from the patients nose.It was confirmed that incorrect results were not reported to the physician, the patient was not harmed or treated incorrectly but there was a 24 hour delay in providing correct results.
 
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Brand Name
CHROMID(TM) MRSA 20 PLT
Type of Device
CHROMID(TM) MRSA 20 PLT
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR  69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR   69280
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5255455
MDR Text Key32325701
Report Number3002769706-2015-00156
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeSP
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 11/13/2015
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 Date11/13/2015
Device Catalogue Number43451
Device Lot Number1004254660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2015
Initial Date FDA Received11/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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