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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD

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BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD Back to Search Results
Catalog Number 21347
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)(6) contacted biomerieux to report a discrepant (b)(6) organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit.Corynebacterium ulcerans was misidentified as corynebacterium minutissinum.Upon retesting, the correct result of corynebacterium ulcerans was obtained.There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.No patient was directly associated with the abp survey result.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.
 
Manufacturer Narrative
Biomérieux investigation was conducted.Investigational testing included: - vitek® 2 anc id cards (customer lot expired, so two random lots were tested) to check the customer result, - vitek® ms, - api® coryne strip.Results: - vitek® 2 anc id: excellent identification to corynebacterium ulcerans, for both lots tested.- vitek® ms: excellent identification to the species corynebacterium ulcerans.- api® coryne strip: doubtful profile with a possibility of corynebacterium minutissimum.The investigation did not reproduce the vitek® 2 anc id misidentification to the species corynebacterium minutissimum obtained by the customer.The investigation also determined the customer was sub-culturing to a non-recommended media.The customer retested with recommended media (cba) and obtained the correct result.The misidentification appears to be related to the use of non-recommended media by the customer.Based on the results of the investigation, the vitek® 2 anc id is performing as expected.
 
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Brand Name
VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
Type of Device
VITEK® 2 ANC CARD
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5329407
MDR Text Key34474215
Report Number1950204-2015-00130
Device Sequence Number1
Product Code JSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K910666
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 12/02/2015
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 Date01/06/2016
Device Catalogue Number21347
Device Lot Number244331010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2015
Initial Date FDA Received12/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2014
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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