VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-13 for VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux Inc..

Event Text Entries

[120259125] A customer from the united states notified biom? Rieux of misidentification results for cap survey specimen d09 when testing with the vitek? 2 gn id card (ref (b)(4)). The expected id was acinetobacter lwoffii, and the gn card identified the sample as acinetobacter baumannii twice. Initial testing was performed with the lot 2410481403. Repeat testing was performed with this lot, # 2410595203. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00362
MDR Report Key7875080
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-09-13
Date of Report2018-10-17
Date Mfgr Received2018-09-18
Device Manufacturer Date2018-07-14
Date Added to Maude2018-09-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
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 NEGATIVE IDENTIFICATION TEST KIT
Generic NameVITEK? 2 GN ID TEST KIT
Product CodeLQM
Date Received2018-09-13
Catalog Number21341
Lot Number2410595203
Device Expiration Date2019-07-14
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 2018-09-13

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