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 Number: 129655
• MDR Report Key: 129655
• Date Received: 1997-07-01
• Date of Report: 1996-06-17
• Date of Event: 1996-05-19
• Date Facility Aware: 1996-05-30
• Report Date: 1996-06-18
• Date Added to Maude: 1997-11-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BFA
• Generic Name: COAGULATION INSTRUMENT
• Product Code: GKT
• Date Received: 1997-07-01
• Model Number: *
• Catalog Number: OVSB03
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 42 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 126811
• Manufacturer: BEHRING DIAGNOSTIC, INC.
• Manufacturer Address: 3403 YERBA BUENA RD. SAN JOSE CA 951619013 US

Device Sequence Number: 2

• Brand Name: REAGENT PATHROMPTIN
• Generic Name: REAGENT
• Product Code: GIT
• Date Received: 1997-07-01
• Model Number: *
• Catalog Number: REAGENT OQ65
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 42 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 126813
• Manufacturer: BEHRING DIAGNOSTIC, INC.
• Manufacturer Address: 3403 YERBA BUENA RD. SAN JOSE CA 951619013 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-07-01