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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 GN TEST KIT VITEK® 2 GN 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  
Event Description
A customer from the united states reported to biomérieux a misidentification of an american proficiency institute (api) survey sample in association with the vitek® 2 gn test kit. The api sample, proteus vulgaris, was identified with the vitek® 2 gn card as low discrimination for proteus penneri/hauseri. The customer performed an off line indole test which was positive, and reported the result as proteus hauseri. Repeat testing with vitek® 2 gn identified proteus hauseri. The customer provided the test reports to biomérieux for evaluation. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
A biomérieux internal investigation was conducted on a api survey organism (api proficiency urine ur-11). The organism was tested on multiple lots of gn cards in duplicate, including 4 lots reported by customers and 1 random gn lot. The api 20 e was performed, as was the vitek® ms. On 2 of the customer lots, a low discrimination call of p. Penneri / p. Hauseri was obtained. On the remaining 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). The investigation concluded the submitted isolate exhibits atypical growth behavior. The vitek® 2 gn test kit performed as intended.
 
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Brand NameVITEK® 2 GN TEST KIT
Type of DeviceVITEK® 2 GN 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 Key6216011
MDR Text Key63691026
Report Number1950204-2016-00217
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 02/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2017
Device Catalogue Number21341
Device Lot Number241390140
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 Received01/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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