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