VITEK? 2 GP ID CARD 21342

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 2018-06-06 for VITEK? 2 GP ID CARD 21342 manufactured by Biomerieux Inc..

Event Text Entries

[110661250] A customer in (b)(6) contacted biom? Rieux to report the two occurrences (two different patients) of a misidentification of staphylococcus aureus as staphylococcus lugdunensis in association with the vitek? 2 gram-positive (gp) identification (id) test kit. The isolates were obtained from vaginal swabs. The customer stated they sent the isolates to a partner laboratory for confirmatory testing. The partner lab reported identifications to staphylococcus aureus via maldi-tof method. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00215
MDR Report Key7573809
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-06-06
Date of Report2018-08-15
Date Mfgr Received2018-07-19
Device Manufacturer Date2018-02-14
Date Added to Maude2018-06-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JEFF SCANLAN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318694
Manufacturer G1BIOMERIEUX INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 GP ID CARD
Generic NameVITEK? 2 GP ID CARD
Product CodeLQL
Date Received2018-06-06
Catalog Number21342
Lot Number2420628103
Device Expiration Date2019-08-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX INC.
Manufacturer Address595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-06

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