VIDAS? CA 15-3 ASSAY 30429

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 2018-04-26 for VIDAS? CA 15-3 ASSAY 30429 manufactured by Biomerieux Sa.

Event Text Entries

[106742850] A customer in (b)(6) reported discrepant results for a patient's samples in association with the vidas? Ca 15-3 assay. The (b)(6) 2018 results: vidas first test: 372. 36 iu/ml, vidas second test: 764. 07 iu/ml, roche test: 975ku/l. The (b)(6) 2018 results: vidas first test: 506. 87 iu/ml, vidas second test: 528. 09 iu/ml, roche test: 721ku/l. The customer stated the incorrect (b)(6) 2018 result was reported to the clinician, and that the result affected patient treatment. The customer stated there was discussion to switch the patient therapy , but the customer indicated that they think the therapy has not yet been switched. 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 the 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 Number3002769706-2018-00060
MDR Report Key7465282
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-04-26
Date of Report2018-07-11
Date of Event2018-02-23
Date Mfgr Received2018-06-15
Date Added to Maude2018-04-26
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 RD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX SA
Manufacturer Street376, CHEMIN DE L'ORME
Manufacturer CityMARCY L'ETOILE, 69280
Manufacturer CountryFR
Manufacturer Postal Code69280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS? CA 15-3 ASSAY
Generic NameVIDAS? CA 15-3 ASSAY
Product CodeLTK
Date Received2018-04-26
Catalog Number30429
Lot Number1006022590
Device Expiration Date2018-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address376, CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 69280


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.