ALINITY S HIV AG/AB COMBO 06P01-55

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 2019-10-21 for ALINITY S HIV AG/AB COMBO 06P01-55 manufactured by Abbott Germany.

MAUDE Entry Details

Report Number3002809144-2019-00698
MDR Report Key9214052
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-10-21
Date of Report2019-11-05
Date of Event2019-10-10
Date Mfgr Received2019-11-05
Device Manufacturer Date2019-05-01
Date Added to Maude2019-10-21
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 G1ABBOTT GERMANY
Manufacturer StreetMAX-PLANCK-RING 2
Manufacturer CityWIESBADEN 65205
Manufacturer CountryGM
Manufacturer Postal Code65205
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALINITY S HIV AG/AB COMBO
Generic NameHIV-1 AND HIV-2 ANTIBODIES
Product CodeMZF
Date Received2019-10-21
Catalog Number06P01-55
Lot Number04077BE00
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT GERMANY
Manufacturer AddressMAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

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