CHROMID? CANDIDA AGAR 43631

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 2017-04-25 for CHROMID? CANDIDA AGAR 43631 manufactured by Biom?rieux Sa.

Event Text Entries

[73620466] Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[73620467] A customer in (b)(6) reported the occurrence of false negative (no growth) for yeast from a vaginal specimen. Testing via alternate agar media (cpse, pvx, anc) obtained good growth. Identification testing (vitek? 2 yst id test kit) produced a result of candida albicans. Incubation time allowed by the customer = 48 hours. Instructions for use (ifu) indicate incubation up to 72 hours. Plates were stored at 4? C in a lighted environment. This practice is outside the ifu; the plates should be stored in a manner protected from light. Additionally, the ifu indicates "growth depends on the requirements of each individual microorganism. It is therefore possible that certain yeast strains which have specific requirements (substrate, temperature, etc. ) may not grow or may not produce color. " the customer stated no incorrect result was reported to the treating physician, and there was no adverse impact to the patient's state of health. Biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2017-00077
MDR Report Key6518596
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-04-25
Date of Report2017-08-14
Date Mfgr Received2017-07-19
Device Manufacturer Date2017-01-30
Date Added to Maude2017-04-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOM
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 NameCHROMID? CANDIDA AGAR
Generic NameCHROMID? CANDIDA AGAR
Product CodeJSI
Date Received2017-04-25
Catalog Number43631
Lot Number1005462060
Device Expiration Date2017-05-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOM?RIEUX SA
Manufacturer Address5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-25

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