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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA LYFOCULTS® PLUS CANDIDA KRUSEI

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BIOMERIEUX SA LYFOCULTS® PLUS CANDIDA KRUSEI Back to Search Results
Catalog Number 300959
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 contacted biomerieux to report a discrepant results when using product lyfocults plus candida krusei during an internal quality control test.The customer stated the mic, minimum inhibitory concentration range, of the amphotericina b was:<0,25 and the expected range was 0,50< 2.00.The customer stated that retesting was performed on the subject strain using two different vitek 2 systems; anomalies were noted on both systems qc results.There are no issues with other strains of candida species or testing process; operated correctly all stages of sample preparation including controls on sterility.No patient results were affected or delayed results reported.
 
Manufacturer Narrative
Biomérieux internal investigation was conducted.The customer's qc strain and the in-house qc strain were sub-cultured and amphotericin b testing included two (2) ast-ys07 cards from the same lot as that tested by the customer and two (2) cards from a random lot.All ast-ys07 cards tested for each qc strain provided acceptable mics = 0.5 or 1.The vitek ast-ys07 cards are performing in accordance with specifications.
 
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Brand Name
LYFOCULTS® PLUS CANDIDA KRUSEI
Type of Device
LYFOCULTS® PLUS CANDIDA KRUSEI
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 Key5285950
MDR Text Key33940444
Report Number3002769706-2015-00164
Device Sequence Number1
Product Code JTR
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 11/15/2015
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 Date11/02/2016
Device Catalogue Number300959
Device Lot Number1003575250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2015
Initial Date FDA Received12/10/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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