VITEK? 2 GRAM NEGATIVE ID 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 2018-08-28 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux Inc..

Event Text Entries

[119157072] A customer in the united states contacted biom? Rieux to report a misidentification of escherichia coli as shigella sonnei for a urine isolate in association with the vitek? 2 gram negative (gn) identification (id) test kit. The isolate was a lactose fermenter, indicating an identification of shigella was not possible. Repeat test via different gn id lot number gave an organism identification of escherichia coli. No information was provided by the customer regarding any reference or alternate method testing performed. The customer stated they "bench id'd" the organism. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health. Biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00305
MDR Report Key7822409
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-08-28
Date of Report2018-10-22
Date Mfgr Received2018-09-25
Device Manufacturer Date2018-02-14
Date Added to Maude2018-08-28
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 ContactMR. JEFF SCANLAN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAXELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318805
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 ID TEST KIT
Generic NameVITEK? 2 GN ID TEST KIT
Product CodeLQM
Date Received2018-08-28
Catalog Number21341
Lot Number2410445403
Device Expiration Date2019-02-14
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 2018-08-28

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