BFA * OVSB03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for BFA * OVSB03 manufactured by Behring Diagnostic, Inc..

Event Text Entries

[15485703] Pt admitted with angina of 20 to 30 minute duration. Unrelieved in the er a bolus dose of heparin and an iv of heparin at 1000 u/hr. Follow-up to this was a ptt level ordered for 2200. Lab results reported incorrect due to stirring arm in equipment to keep reagent suspended, was stopped. Pt was discharged 5/20/96.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number129655
MDR Report Key129655
Date Received1997-07-01
Date of Report1996-06-17
Date of Event1996-05-19
Date Facility Aware1996-05-30
Report Date1996-06-18
Date Added to Maude1997-11-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameBFA
Generic NameCOAGULATION INSTRUMENT
Product CodeGKT
Date Received1997-07-01
Model Number*
Catalog NumberOVSB03
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age42 DAY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key126811
ManufacturerBEHRING DIAGNOSTIC, INC.
Manufacturer Address3403 YERBA BUENA RD. SAN JOSE CA 951619013 US

Device Sequence Number: 2

Brand NameREAGENT PATHROMPTIN
Generic NameREAGENT
Product CodeGIT
Date Received1997-07-01
Model Number*
Catalog NumberREAGENT OQ65
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age42 DAY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key126813
ManufacturerBEHRING DIAGNOSTIC, INC.
Manufacturer Address3403 YERBA BUENA RD. SAN JOSE CA 951619013 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-07-01

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