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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 Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
A customer in (b)(6) obtained misidentifications of an e. Cloacae complex on the vitek 2 gn cards ((b)(4)). An internal biomérieux investigation was performed. The submitted isolate was subcultured and testing included vitek® 2 gn cards from the customer's lot and a random lot, in duplicate, vitek® ms and the api® 20e test kit. All four (4) vitek® 2 gn cards tested resulted in excellent slashline identifications of e. Cloacae complex (including e. Kobei). The vitek® ms gave a low discrimination identification of e. Cloacae/e. Asburiae, and the api® 20e resulted in an acceptable identification ((b)(4)) to the genus of e. Cloacae/e. Asburiae. E. Kobei is not in the vitek® ms v2 or api® 20e database. The customer's misidentification was not duplicated. Vitek® 2 gn cards are performing as expected. Review of the k. Oxytoca data, obtained after analysis times of only two (2) hours, against the expected reactions for e. Kobei, demonstrated three (3) atypical positive reactions (ado, iarl and dtag) contributing to the misidentification. An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media, user set up errors, or an atypical strain.
 
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)(6) contacted biomérieux to report a misidentification of enterobacter species as klebsiella oxytoca in association with the vitek® 2 gram-negative (gn) identification (id) test kit. The customer tested three times from the same blood specimen on three different days ((b)(6) 2017) and received the same identification to klebsiella oxytoca. Following the third result of klebsiella oxytoca, the customer determined to test the isolate via malditof and via separate vitek® 2 compact. Malditof identified the isolate as enterobacter kobei. Vitek® 2 compact identified the isolate as enterobacter cloacae complex. During troubleshooting it was determined the customer does not perform routine densichek¿ maintenance, as indicated in the instructions for use (ifu). In addition, all card cassettes are configured simultaneously before introducing them to the instrument; the associated ifu indicate the cards must be placed into the instrument for processing without delay. The local field service engineer (fse) was dispatched to visit the customer site in order to confirm/perform system maintenance/repair as appropriate. The fse did not identify any system issues that may have led to the discrepant organism identification. Follow-up testing of the patient isolate obtained the expected enterobacter result using both vitek® 2 compact systems. The customer stated the klebsiella oxytoca result was reported to the treating physician. However, the customer indicates that the discrepant result did not lead to any adverse event related to any patient's state of health. Culture submittal has been requested by biomérieux for internal investigation. Biomérieux investigation has been initiated.
 
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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 Key6460284
MDR Text Key192865827
Report Number1950204-2017-00111
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCO
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 06/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2017
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
Other Device ID Number03573026131913
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 Received06/01/2017
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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