TRIAGE METER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-19 for TRIAGE METER * manufactured by Biosite.

Event Text Entries

[21625229] The pt was seen on 10/17/99 because of chest pain and elevated enzymes, pt transported 50 miles and admitted to coronary unit. The enzymes ran at the new facility were normal. A vq scan & echocardiogram were performed with normal results. This is no the first time facility has received elevated results which turned out to be normal. The serum which gave elevated results was sent to the new facility referrence lab where results came back normal. There is an underlying problem with the analytical procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	247213
MDR Report Key	247213
Date Received	1999-10-19
Date of Report	1999-10-19
Date of Event	1999-10-17
Date Facility Aware	1999-10-17
Report Date	1999-10-19
Date Reported to FDA	1999-10-19
Date Reported to Mfgr	1999-10-19
Date Added to Maude	1999-11-02
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 Details

Brand Name	TRIAGE METER
Generic Name	CARDIAC METER
Product Code	JHY
Date Received	1999-10-19
Model Number	TRIAGE METER
Catalog Number	*
Lot Number	REAGENT W17051B
ID Number	*
Device Expiration Date	2000-01-01
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	NO INFO
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	239489
Manufacturer	BIOSITE
Manufacturer Address	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1999-10-19