ETEST? DAPTOMYCIN DPC 256 WW F100 535018

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 2018-03-27 for ETEST? DAPTOMYCIN DPC 256 WW F100 535018 manufactured by Biomerieux Sa.

Event Text Entries

[103947499] A customer from (b)(6) reported out of range low results for internal quality controls (qc) in association with etest? Daptomycin dpc 256 ww f100 (reference 535018) lot 1004343910. The customer stated that when their qc is within range it is always at the very lowest end of the qc range for both the staphylococcus aureus atcc? 29213 and enterococcus faecalis atcc? 29212. The customer reported that when the qc is out of range, it is always lower than expected. The customer reported that results were delayed at least 72 hours for two (2) patients (with vre in the blood) due to the daptomycin qc failing at least twice. 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 a 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 Number3002769706-2018-00048
MDR Report Key7374662
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-03-27
Date of Report2018-06-19
Date Mfgr Received2018-05-25
Device Manufacturer Date2015-10-02
Date Added to Maude2018-03-27
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 ContactMS. ELLEN WELTMER
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal27712
Manufacturer G1BIOMERIEUX SA
Manufacturer Street3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETEST? DAPTOMYCIN DPC 256 WW F100
Generic NameETEST? DAPTOMYCIN DPC 256 WW F100
Product CodeJWY
Date Received2018-03-27
Catalog Number535018
Lot Number1004343910
Device Expiration Date2018-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-27

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