VIDAS? MEASLES IGG ASSAY 30219

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-13 for VIDAS? MEASLES IGG ASSAY 30219 manufactured by Biomerieux Sa.

Event Text Entries

[35922762] Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[35922763] A customer in the united states reported a discrepancy in results with the vidas easles igg test. There is no indication or report from the hospital to biomerieux that the associated invalid avidity results led to any adverse event related to a patient's state of health. Submittal of the patient sample has been requested. Biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


[41282864] Biom? Rieux internal investigation was conducted. However, the customer did not comply with biom? Rieux request for sample submittal and the referenced product lot was already expired. Analysis of the manufacturing qc batch record showed no abnormality. As indicated in the instructions for use, vidas? Measles igg performance does not claim 100% in term of specificity or sensitivity. Vidas? Measles igg and arup use different testing methods; they are qualitative elfa test and semi-quantitative chemiluminescent test, respectively. Without the arup performance specifications (sensitivity and specificity) and the lack of third confirmatory method, it is not possible to determine which result is correct. The investigation concluded that no product performance issue was confirmed for the referenced lot of vidas? Measles igg assay.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002769706-2016-00007
MDR Report Key5364749
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-01-13
Date of Report2015-10-16
Date Mfgr Received2015-10-16
Device Manufacturer Date2014-11-21
Date Added to Maude2016-01-13
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 ContactMR. RYAN LEMELLE
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147318582
Manufacturer G1BIOMERIEUX SA
Manufacturer StreetCHEMIN DE L ORME
Manufacturer CityMARCY L ETOILE, RHONE 69280
Manufacturer CountryFR
Manufacturer Postal Code69280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS? MEASLES IGG ASSAY
Generic NameVIDAS? MEASLES IGG ASSAY
Product CodeLJB
Date Received2016-01-13
Catalog Number30219
Lot Number1003574790
Device Expiration Date2015-09-16
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 69280


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-13

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