CHROMID? VRE ID AGAR 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 2018-10-15 for CHROMID? VRE ID AGAR 43004 manufactured by Biomerieux S.a..

Event Text Entries

[126090750] On (b)(6) 2018, a customer in (b)(6) reported a no growth result obtained on (b)(6) 2018, for a vancomycin resistant enterococcus faecium eeq quality control survey strain, in association with chromid? Vre id agar (lot. # 1006476480, expiry 30jul2018). The customer stated that no growth was observed after 24 and 48 hours of incubation at 37? C. The agar was stored at 2-8? C protected from the light. No quality control was performed. There was no patient involvement as the event pertained to a quality control sample. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2018-00215
MDR Report Key7965728
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-10-15
Date of Report2019-02-27
Date of Event2018-07-04
Date Mfgr Received2019-01-29
Device Manufacturer Date2018-05-03
Date Added to Maude2018-10-15
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
Generic NameCHROMID? VRE ID AGAR
Product CodeJSO
Date Received2018-10-15
Catalog Number43004
Lot Number1006476480
Device Expiration Date2018-07-30
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 2018-10-15

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