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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID CARD

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BIOMERIEUX, INC VITEK® 2 NEISSERIA HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID CARD Back to Search Results
Catalog Number 21346
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4) - this mdr is part of the 227 pilot program. Biomérieux internal investigation was conducted for events #1 and #2. Patient isolates were submitted by the customer for event #1. The investigation determined the customer had not used the correct mcfarland value (0. 5 instead of 3. 0) during patient isolate preparation. Testing with the correct mcfarland value provided the expected result. The investigation concluded the vitek® 2 nh id cards are performing in accordance with specifications. No patient isolates were received for event #2. Two lab reports were submitted by the customer. Lab report #1 showed a haemophilus parainfluenzae identification. There were 7 atypical reactions for haemophilus influenzae. Lab report #2 showed a low discrimination result between haemophilus parainfluenzae and haemophilus haemolyticus. There were 6 atypical reactions for haemophilus influenzae. No other information or submittal was provided by the customer. An increase in atypical reactions can indicate an atypical strain, a deviation from the recommended set up procedure, contamination or mixed culture. Without the strain and raw data, it's not possible to further evaluate the misidentification. Both vitek 2 nh id lots used by the customer (245342740 and 245352920 passed qc performance testing. Device not returned to manufacturer.
 
Event Description
This report summarizes 3 malfunction events. A review of the events indicated that testing via the vitek® 2 neisseria haemophilus (nh) id test kit resulted in organism misidentifications. Misidentification of neisseria gonorrhoeae as neisseria cinerea, misidentification of haemophilus influenzae as haemophilus parainfluenzae, misidentification of campylobacter jejuni (b)(4) as campylobacter coli. Events 1 and 2 involved patient organism identification test results. Neither of the events led to any adverse event related to a patient's state of health. Event 3 involved a quality contorl (qc) organism, and was not related to any patient. Culture submittals and raw test data were requested for each event.
 
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Brand NameVITEK® 2 NEISSERIA HAEMOPHILUS IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 NH 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 Key5596868
MDR Text Key43289687
Report Number1950204-2016-00045
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
K842587
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 04/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21346
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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 Initial

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