ALINITY I TOTAL PSA REAGENT KIT 07P92-30

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 2020-02-11 for ALINITY I TOTAL PSA REAGENT KIT 07P92-30 manufactured by Abbott Ireland Diagnostics Division.

MAUDE Entry Details

Report Number3008344661-2020-00014
MDR Report Key9695211
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-11
Date of Report2020-03-24
Date of Event2019-12-03
Date Mfgr Received2020-03-19
Date Added to Maude2020-02-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 G1ABBOTT IRELAND DIAGNOSTICS DIVISION
Manufacturer StreetFINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION
Manufacturer CitySLIGO NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALINITY I TOTAL PSA REAGENT KIT
Generic NamePROSTATIC SPECIFIC ANTIGEN (PSA)
Product CodeMTF
Date Received2020-02-11
Catalog Number07P92-30
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT IRELAND DIAGNOSTICS DIVISION
Manufacturer AddressFINISKLIN BUSINESS PARK DIAGNOSTICS DIVISION SLIGO NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-11

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