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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 CARD

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BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2015
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A customer in (b)(6) reported the vitek 2 gram-negative (gn) id test kit provided inconsistent identification results for a single patient isolate. The initial gn id test obtained a result of klebsiella oxytoca. The customer always performs an indole test for this organism; the result was negative, which the customer considered odd for this organism id. The customer retested the isolate via gn id card; the repeat test provided klebsiella pneumoniae. Both gn id cards were inoculated from the same blood culture bottle. Klebsiella oxytoca was reported to the physician despite the negative indole result; this is because of the excellent identification (98%) reported by the vitek 2 gn id card. The customer performed no testing of the isolate via alternate method. Therefore; there is no confirmation of either result. Biomerieux has requested submittal of patient isolate for internal testing. There is no indication or report from the hospital or treating physician to biomerieux that the organism misidentification led to any adverse event related to the patient's state of health. An internal biomerieux investigation will be initiated.
 
Manufacturer Narrative
Biomérieux internal investigation was conducted. Testing included the customer lot and two (2) random lots of vitek® 2 gn id cards. Api® 20 e was also performed. On the customer lot and one random lot of gn id cards, an id of klebsiella pneumoniae ssp pneumoniae was obtained. On the second random lot of gn id cards, an id of klebsiella oxytoca was obtained. Api® 20 e gave an id of klebsiella pneumoniae ssp pneumoniae. Therefore, the final identification is k. Pneumoniae ssp pneumoniae. A comparison of reaction results for the card giving the klebsiella oxytoca identification against the expected reaction results for klebsiella pneumoniae ssp pneumoniae revealed one atypical positive reaction (5kg) that contributed to the misidentification. It should also be noted that the analysis time for the card giving a klebsiella oxytoca identification (3. 75 hours) was much shorter than that for cards giving the correct identification (8. 25-8. 50 hours). The investigation concluded that the patient isolate is an atypical strain having irregular or inconsistent growth characteristics. The vitek® 2 gn id cards are performing as expected.
 
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Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 GN ID 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
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5366270
MDR Text Key36060515
Report Number1950204-2016-00007
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCA
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 12/24/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/16/2016
Device Catalogue Number21341
Device Lot Number241356410
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 Received12/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2015
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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