CHROMID? VRE ID AGAR 20 PLT 43004

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 2018-09-17 for CHROMID? VRE ID AGAR 20 PLT 43004 manufactured by Biomerieux S.a..

Event Text Entries

[120736565] A customer in (b)(6) reported false positive results when using chromid? Vre id agar 20 plt (lot 1006583800). The customer performed tests with rectal samples from three (3) patients, and growth of typical purple colonies of enterococcus faecium vancomycin b were obtained. The identification of the strains was confirmed as enterococcus faecium with mass spectrometry. The customer stated that qc results were conforming. The customer tested the strains on the vitek? 2 ast-p606 card and the results were vancomycin susceptible the customer sent the strains to another laboratory (cnr) and the results were negative with pcr and microdilution. The customer stated that the results were reported to the clinician and the patients were isolated unnecessarily. The patients did not have antibiotic treatment. 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 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 Number3002769706-2018-00183
MDR Report Key7882152
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-09-17
Date of Report2018-11-13
Date Mfgr Received2018-10-19
Device Manufacturer Date2018-06-19
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 G1BIOMERIEUX S.A.
Manufacturer Street5 RUE DES AQUEDUCS
Manufacturer CityCRAPONNE, 69290
Manufacturer CountryFR
Manufacturer Postal Code69290
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMID? VRE ID AGAR 20 PLT
Generic NameCHROMID? VRE ID AGAR 20 PLT
Product CodeJSO
Date Received2018-09-17
Catalog Number43004
Lot Number1006583800
Device Expiration Date2018-09-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX S.A.
Manufacturer Address5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-17

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