ARCHITECT TOTAL B-HCG 07K78-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-25 for ARCHITECT TOTAL B-HCG 07K78-30 manufactured by A.i.d.d Longford.

MAUDE Entry Details

Report Number3005094123-2019-00331
MDR Report Key9370798
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-25
Date of Report2019-11-25
Date Mfgr Received2019-11-17
Date Added to Maude2019-11-25
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 ContactCHRISTIAN LEE
Manufacturer Street100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224668-294
Manufacturer G1A.I.D.D LONGFORD
Manufacturer StreetLISNAMUCK CO. LONGFORD
Manufacturer CityLONGFORD NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT TOTAL B-HCG
Generic NameB-HCG
Product CodeDHA
Date Received2019-11-25
Catalog Number07K78-30
Lot Number01177UI00
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerA.I.D.D LONGFORD
Manufacturer AddressLISNAMUCK CO. LONGFORD LONGFORD NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-25

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