VITEK? 2 GN 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 2018-09-17 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..

Event Text Entries

[120734999] A customer in the united states reported misidentifications of four (4) strains from three (3) cystic fibrosis patients in association with the vitek? 2 gn test kit. The gn card identified bordetella hinzi for all four (4) isolates. A physician suspected the identification should be achromobacter, so three (3) isolates were sent to an external lab (arup) for identification (maldi-tof). The following identifications were obtained: (b)(6) - achromobacter species; (b)(6) - achromobacter species; (b)(6)- kerstersia gyiorum. The customer reported that there was no impact to patient treatment, and the physician did not allege that the results caused him to act incorrectly. It was mentioned that patient (b)(6) had been admitted to a hospital a week or two prior to being seen in the customer's clinic. The hospital identified an achromobacter (maldi-tof) from the patient's sputum. 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 will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00368
MDR Report Key7881260
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-09-17
Date of Report2018-11-28
Date Mfgr Received2018-10-30
Device Manufacturer Date2018-06-25
Date Added to Maude2018-09-17
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. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318805
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 GN TEST KIT
Generic NameVITEK? 2 GN TEST KIT
Product CodeLQM
Date Received2018-09-17
Catalog Number21341
Lot Number2410576403
Device Expiration Date2019-06-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-17

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