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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: the organism was tested on multiple lots of gn cards in duplicate, including four (4) lots reported by customers and one (1) random gn lot. The api 20 e was performed, as was the vitek® ms. On two (2) of the customer lots, a low discrimination call of p. Penneri / p. Hauseri was obtained. On the remaining two (2) customer lots tested and the random lot, a low discrimination call of p. Penneri / p. Pneumotropica was obtained. Api 20 e gave a good identification call of p. Vulgaris group. Vitek® ms gave a low discrimination call of p. Penneri / p. Vulgaris. Since the organism is indole positive, the vitek® ms call of p. Vulgaris would be correct. A comparison of reaction results for cards giving the misidentification call of p. Penneri / p. Hauseri against the expected reaction results for p. Vulgaris revealed 3 atypical negative reactions (ple, ilatk, aglu). A comparison of reaction results for cards giving the misidentification call of p. Penneri/p. Pneumotropica against the expected reaction results for p. Vulgaris revealed 4 atypical negative reactions (proa, ple, ilatk, aglu). This is an atypical isolate.
 
Event Description
A customer from the united states reported to biomérieux a misidentification of an api proficiency test urine sample of proteus vulgaris, as proteus penneri in association with the vitek® 2 gn id test kit. The organism was cultured 24-48 hours on bap/tsab/blood agar, using mcfarland range 0. 5-0. 63. The customer repeated the test with an 18-24 hour culture, using mcfarland 0. 60 and 0. 57. The identification result was proteus penneri. The vitek®2 gn test reports and the proficiency results were requested from the customer. An internal biomérieux investigation will be initiated.
 
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Brand NameVITEK® 2 GN ID TEST KIT
Type of DeviceVITEK® 2 GN ID TEST 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
ellen weltmer
595 anglum road
st. louis, MO 63042
3147317301
MDR Report Key6262452
MDR Text Key247121300
Report Number1950204-2017-00013
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
C1, EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2017
Device Catalogue Number21341
Device Lot Number241373140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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