ALERE DETERMINE HIV-1/2 AG/AB COMBO 7D2648

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for ALERE DETERMINE HIV-1/2 AG/AB COMBO 7D2648 manufactured by Abbott Diagnostics Scarborough, Inc..

MAUDE Entry Details

Report Number1221359-2020-00011
MDR Report Key9818603
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-01-27
Date Mfgr Received2020-01-29
Device Manufacturer Date2019-12-18
Date Added to Maude2020-03-11
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 ContactMRS. ERIN ROWLEY
Manufacturer Street10 SOUTHGATE ROAD
Manufacturer CitySCARBOROUGH, ME
Manufacturer CountryUS
Manufacturer Phone7305858
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALERE DETERMINE HIV-1/2 AG/AB COMBO
Generic NameIVD FOR HIV 1/2 AG/AB
Product CodeMZF
Date Received2020-03-11
Catalog Number7D2648
Lot Number115049
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT DIAGNOSTICS SCARBOROUGH, INC.
Manufacturer Address10 SOUTHGATE ROAD SCARBOROUGH, ME US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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