VIDAS? D DIMER II 30455

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 2017-11-09 for VIDAS? D DIMER II 30455 manufactured by Biomerieux Sa.

Event Text Entries

[92608614] A customer in (b)(6) notified biom? Rieux of discrepant results associated with vidas? D dimer ii (reference 30455). The customer reported a d dimer result of less than 40 ng/ml. The sample was retested three (3) times and tested on a different vidas? System, but the result obtained was less than 40 ng/ml. There was a delay in reporting the results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2017-00355
MDR Report Key7014395
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-11-09
Date of Report2018-02-01
Date Mfgr Received2018-01-05
Date Added to Maude2017-11-09
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 Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX SA
Manufacturer StreetCHEMIN DE L ORME MARCY L ETOILE, RHONE 69280
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS? D DIMER II
Generic NameVIDAS? D DIMER II
Product CodeDAP
Date Received2017-11-09
Catalog Number30455
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer AddressCHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-09

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