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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 GN TEST KIT

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BIOMERIEUX, INC VITEK 2 GN TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of a misidentification in association with the vitek® 2 gn test kit (ref 21341). The customer reported the vitek® 2 gn test kit identified the organism as shigella; however, the strain was sent to the cnr for identification and the result came back as other than shigella. The customer reports that the sample was tested a total of three (3) times by the vitek® 2 instrument. Although this was a patient sample (urine), based on the information provided, there was no adverse events, negative patient impact or delay in results; however, incorrect results were reported to the physician. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
An internal biomérieux investigation was performed. After incubation, a heterogeneous population (called colony a and colony b) was observed. The expected result was confirmed on vitek® ms: identification to the species e. Coli (99. 9%) with both colonies. With id32e strip, an excellent identification to e. Coli (99. 9%) with one (1) test against (adh
=
3%) for colony a and none for colony b was obtained. The organism was subcultured on cba media and tested on two (2) vitek® 2 gn cards (customer lot 241385440 and random lot 241391540). On vitek® 2, with colony a on both vitek® 2 gn cards (customer and random lot) tested in-house, an excellent identification to escherichia coli (99%) was obtained. With colony b, on the customer lot, a low discrimination between esherichia coli and shigella group was obtained. With the random lot, a good identification to shigella group with the same biochemical profile of the customer result was obtained. After comparison of biochemical profiles between this profile (rl) obtained in-house and the expected profiles of e. Coli inactive, biomerieux observed three (3) tests against e. Coli inactive: bgal (96), llatk (4%) ldc. (4%). It should be noted that, when an identification of shigella is made by vitek® 2 gn cards, an analysis message of "confirm by serological tests" is given. Biomérieux duplicated the customer misidentification only on the random lot and the colony b due to the atypical biochemical profile of the isolate. In conclusion, we have a mix population with one e. Coli (colony a) and one e. Coli inactive(colony b). Root cause: mixed culture - colony a- correct id. Colony b - atypical strain. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.
 
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Brand NameVITEK 2 GN TEST KIT
Type of DeviceVITEK 2 GN TEST KIT
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
ellen weltmer
595 anglum road
st. louis, MO 63042
MDR Report Key6148861
MDR Text Key61602705
Report Number1950204-2016-00198
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 03/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/03/2017
Device Catalogue Number21341
Device Lot Number241385440
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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