STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY * B5700-64

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1998-01-19 for STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY * B5700-64 manufactured by Dade Intl., Inc..

Event Text Entries

[73214] Customer called into stratus technical services requesting that co test a pt sample for them. They indicated that they had a pt sample with a troponin-i result of <0. 35 ng/ml (negative). They sent the sample to a sister hospital for testing and the result was positive. No pt info was given.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1025506-1998-00001
• MDR Report Key: 145242
• Report Source: 05,06,07
• Date Received: 1998-01-19
• Date of Report: 1998-01-19
• Date of Event: 1997-11-14
• Date Mfgr Received: 1997-12-16
• Device Manufacturer Date: 1997-10-01
• Date Added to Maude: 1998-01-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: MEDICAL TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNOASSAY
• Generic Name: TROPONIN-I
• Product Code: LGP
• Date Received: 1998-01-19
• Model Number: *
• Catalog Number: B5700-64
• Lot Number: KXTN-670
• ID Number: *
• Device Expiration Date: 1999-04-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NA
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 141605
• Manufacturer: DADE INTL., INC.
• Manufacturer Address: 2173 N.W. 99TH AVE. MIAMI FL 33172 US
• Baseline Brand Name: STRATUS CARDIAC TROPONIN-1 FLUOROMETRIC ENZYME IMMUNOASSAY
• Baseline Generic Name: TROPONIN-I
• Baseline Model No: *
• Baseline Catalog No: B5700-64
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	1998-01-19