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 foreign,health professional,u report with the FDA on 2018-09-12 for VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux Inc..

Event Text Entries

[120109884] A customer in (b)(6) contacted biom? Rieux to report a misidentification of serratia marcescens as yersinia pestis for a canine cerebral spinal fluid specimen in association with the vitek? 2 gram negative (gn) identification (id) test kit (card). The yersinia pestis result was obtained via vitek? Ms testing at another laboratory. The isolate was also sent to a second independent laboratory; the isolate was tested with bruker maldi-tof, and also confirmed the id as a serratia marcescens. 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 (canine) state of health. Biom? Rieux requested strain submittal from the customer. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00355
MDR Report Key7868714
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-09-12
Date of Report2018-11-14
Date Mfgr Received2018-10-23
Device Manufacturer Date2018-05-12
Date Added to Maude2018-09-12
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 Phone3147318694
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 Received2018-09-12
Catalog Number21341
Lot Number2410532203
Device Expiration Date2019-05-12
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 2018-09-12

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