VITEK? 2 GRAM POSITIVE ID TEST KIT 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 2018-05-10 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux Inc..

Event Text Entries

[108503110] A customer from (b)(6) notified biom? Rieux of misidentification results for an rcpa eqa quality control strain when testing with vitek? 2 gp id test kit (ref. 21342). The intended result was abiotrophia defectiva, and vitek 2 identified the organism as granulicatella adiacens. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00183
MDR Report Key7502227
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-05-10
Date of Report2018-06-25
Date Mfgr Received2018-06-05
Device Manufacturer Date2017-04-01
Date Added to Maude2018-05-10
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 ContactMRS. CANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CitySAINT LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 GRAM POSITIVE ID TEST KIT
Generic NameVITEK? 2 GP ID TEST KIT
Product CodeLQL
Date Received2018-05-10
Catalog Number21342
Lot Number2420309403
Device Expiration Date2018-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX INC.
Manufacturer Address595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-10

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