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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  
Manufacturer Narrative
A biomérieux investigation was conducted. The submitted isolate was subcultured and the vitek® 2 gn card testing included individual organism suspensions on each of the two customer implicated lots (b)(4), as well as a random lot, in duplicate. The api 20 e test strip was also perfomed. All six (6) gn cards tested resulted in the same low discrimination identification of proteus penneri/proteus hauseri. The api 20 test strip resulted in an excellent identification (b)(4) of proteus vulgaris group. Note, the isolate demonstrated was swarming on tsab agar, compatible with an identification of proteus vulgaris. A review of the customer's proteus penneri/proteus hauseri data against expected reactions for proteus vulgaris demonstrated five (5) atypical negative reactions (off, bglu, proa, 0129r and ggaa) contributing to the misidentification according to the gn knowledge base. Review of the internal proteus penneri/proteus hauseri data demonstrated three of the same atypical negative reactions (bglu, proa and ggaa). An increased number of atypical negative results can indicate a strain with decreased viability or an atypical strain. The investigation concluded the isolate exhibits atypical growth behavior. The vitek® 2 gn card is performing as intended.
 
Event Description
A customer in (b)(6) contacted biomérieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek® 2 gn test kit. The repeat test obtained proteus hauseri. There was no patient involvement associated with the quality control strain. The customer submitted the isolate to biomérieux for evaluation.
 
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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 Key6457616
MDR Text Key71906515
Report Number1950204-2017-00109
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
C1, 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
Report Date 04/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2017
Device Catalogue Number21341
Device Lot Number241396640
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 Received03/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2016
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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