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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 TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)64) contacted biomérieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek® 2 gram-negative (gn) identification (id) test kit. Repeat test obtained proteus hauseri. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the external control strain. Culture submittal has been requested by biomérieux for internal investigation. Biomérieux investigation will be initiated.
 
Manufacturer Narrative
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 gram-negative (gn) identification (id) test kit. Repeat test obtained proteus hauseri. An internal biomérieux investigation was performed. The submitted isolate was subcultured and vitek® 2 gn card testing included individual organism suspensions on each of the two (2) customer implicated lots (241394340 and 241396640) as well as a random lot, in duplicate. Also performed was api® 20 e test strip testing. All six (6) vitek® 2 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 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), according to the gn knowledge base, contributing to the misidentification. Review of the internal proteus penneri/proteus hauseri data demonstrated three (3) 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.
 
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Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID 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
hazelwood, MO 63042
3147317301
MDR Report Key6368612
MDR Text Key68974755
Report Number1950204-2017-00078
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeSF
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 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number21341
Device Lot Number241394340
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 Received03/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2016
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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