VITEK? 2 GN TEST KIT 21341

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-31 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..

Event Text Entries

[127218067] An investigation was performed. The internal biomerieux cap d-09 (2018) survey strain was subcultured to tsab and macconkey agar and incubated to 35-37? C for 20-22 hours. A second subculture was performed and testing included individual organism suspensions with gn cards from four different gn card lots in duplicate as well as vitek ms. (b)(4) (biomerieux internal cap d-09 strain): the strain grew on mac agar as a non-lactose fermenting isolate. All eight gn cards tested resulted in low discrimination identifications of acinetobacter lwoffii/moraxella group. Vitek ms resulted in an identification of acinetobacter lwoffii with a 99. 9% confidence value. As a. Lwoffii was part of the low discrimination call on all gn cards tested, vitek 2 cards are performing as expected. No further action is required.
Patient Sequence No: 1, Text Type: N, H10


[127218068] A customer in (b)(6) reported a misidentification of an acinetobacter lwoffii cap survey strain (d-09) as moraxella group with the vitek? 2 gn test kit (2410478203). The customer reported a result of moraxella group and found out later that the expected result was acinetobacter lwoffi, acinetobacter junii (lwoffi/johnsonii), or acinetobacter sp. The biom? Rieux local field application specialist tested the isolate on the vitek systems of the reporting customer and another customer, and the result was moraxella group. The isolate was identified as acinetobacter lwoffii with vitek ms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00454
MDR Report Key8025947
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-10-31
Date of Report2018-10-31
Date Mfgr Received2018-10-04
Device Manufacturer Date2018-03-19
Date Added to Maude2018-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 GN TEST KIT
Generic NameVITEK? 2 GN TEST KIT
Product CodeLQM
Date Received2018-10-31
Catalog Number21341
Lot Number2410478203
Device Expiration Date2019-03-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-31

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