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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA CHROMID(TM) VRE AGAR
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BIOMERIEUX SA CHROMID(TM) VRE AGAR Back to Search Results
Catalog Number 43851
Device Problem Unable to Obtain Readings (1516)
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 reported product malfunction when using chromid vre agar; the agar dropped from the plate after incubation.The plates were incubated for 24 hours; after incubation the agar was thinner than expected.Customer stated no patient results were affected, no results were reported to physician, and there was a delay of > 24 hours in order to repeat test.
 
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Brand Name
CHROMID(TM) VRE AGAR
Type of Device
CHROMID(TM) VRE AGAR
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 Key5204469
MDR Text Key30500356
Report Number3002769706-2015-00139
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
PMA/PMN Number
K091025
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 10/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number43851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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