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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD

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BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)(6) discrepant results for a patient isolate in association with the vitek (tm) 2 gram-negative (gn) id test kit. On separate tests, the isolate was identified as escherichia coli and pasteurella multocida. The customer did not indicate that any confirmatory testing was performed via an alternate method. The customer did not indicate which result, if either, was reported to the physician. There is no indication or report from the hospital or treating physician to biomerieux that the discrepant results led to any adverse event related to the patient's state of health. Biomerieux has requested submittal of patient isolate for internal testing. An internal biomerieux investigation will be initiated.
 
Manufacturer Narrative
Biomérieux internal investigation was conducted. Investigational testing included: vitek 2 gn id (customer lot): low discrimination pasteurella multocida/canis. Vitek 2 gn id (random lot): low discrimination pasteurella multocida/canis. Vitek ms: identification to pasteurella multocida. The 16s sequencing: identification to pasteurella multocida. Id32e strip: identification to pasteurella multocida. The investigation did not reproduce the discrepant results reported by the customer. The investigation concluded that the vitek 2 gn id cards are performing in accordance with specifications.
 
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Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID 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 Key5351203
MDR Text Key35288262
Report Number1950204-2016-00002
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
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
Type of Report Initial,Followup
Report Date 12/18/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2016
Device Catalogue Number21341
Device Lot Number241352310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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