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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID(TM) CPS® ELITE TRANSLUCENT
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BIOMERIEUX SA CHROMID(TM) CPS® ELITE TRANSLUCENT Back to Search Results
Catalog Number 418284
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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 contacted biomerieux to report discrepant results associated with chromid(tm) cps elite medium.Three isolates of staphylococcus saprophyticus were not identified appropriately; the specimen was from a urine sample.No patient results were delayed as additional testing was performed using a different media.No additional information has been provided.
 
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Brand Name
CHROMID(TM) CPS® ELITE TRANSLUCENT
Type of Device
CHROMID(TM) CPS® ELITE TRANSLUCENT
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 Key5195622
MDR Text Key30168845
Report Number3002769706-2015-00134
Device Sequence Number1
Product Code JXA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
CL I, EXEMPT
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 10/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/23/2015
Device Catalogue Number418284
Device Lot Number1004187290
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/28/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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