ABBOTT AXSYM SYSTEM 7A83-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-19 for ABBOTT AXSYM SYSTEM 7A83-01 manufactured by Abbot Manufacturing, Inc..

Event Text Entries

[419038] The account generated a negative axsym hcv result on a patient who prevoiusly tested axsym hcv reactive. Every year the patient tests axsym hcv reactive (s/co =2. 2). This time, the patient tested axsym hcv negative (s/co =0. 7). No additional testing was performed on the specimen. No patient clinical information is available. The negative axsym hcv result was not reported outside of the laboratory. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2005-00030
MDR Report Key622931
Report Source06
Date Received2005-07-19
Date of Report2005-07-18
Date of Event2005-06-10
Date Mfgr Received2005-06-10
Device Manufacturer Date1994-07-01
Date Added to Maude2005-07-28
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 Location0
Manufacturer ContactDAVID BARCH M.D.
Manufacturer Street100 ABBOTT PARK ROAD D-09Y6, AP6C-2
Manufacturer CityABBOTT PARK IL 600646092
Manufacturer CountryUS
Manufacturer Postal600646092
Manufacturer Phone8479379328
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABBOTT AXSYM SYSTEM
Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Product CodeLCI
Date Received2005-07-19
Model NumberNA
Catalog Number7A83-01
Lot NumberNA
ID NumberNA
OperatorUNKNOWN
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key612576
ManufacturerABBOT MANUFACTURING, INC.
Manufacturer Address1921 HURD DR. IRVING TX 75038 US
Baseline Brand NameABBOTT AXSYM SYSTEM
Baseline Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Baseline Model NoNA
Baseline Catalog No7A83-01
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-07-19

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