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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 association de biologie praticienne (abp) survey organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit.Bacteroides fragilis was misidentified as bacteroides ureolyticus.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to a 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 internal investigation was conducted with the patient isolate submitted by the customer.Testing performed: gram stain to confirm organism orientation; 16s sequencing; vitek® 2 anc id card (customer lot and random lot); vitek® ms; api® 20a strip; rapid id32a strip.Testing results: gram coloration indicates presence of coccobacillus, gram negative; 16s sequencing provided result of bacteroides fragilis; vitek® ms: bacteroides fragilis; rapid id 32a: bacteroides fragilis; api® 20a: bacteroides fragilis; vitek® 2 anc id card (both lots, customer and random) provided identification to bacteroides fragilis.The misidentification reported by the customer was not reproduced.The vitek® 2 anc id cards performed in accordance with specifications.
 
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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 Key5153769
MDR Text Key28416100
Report Number1950204-2015-00069
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 Followup
Report Date 09/30/2015
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 Date11/02/2015
Device Catalogue Number21347
Device Lot Number244324540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2014
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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