FDA Adverse Event
Summary report: N
BIOSITE
MDR report key: 1792900
·
Received July 27, 2010
Report
- Report Number
- 1792900
- Date Received
- July 27, 2010
- Date of Event
- February 15, 2010
- Report Date
- June 29, 2010
- Manufacturer
- INVERNESS MEDICAL
- Product Code
- NBC
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
POINT OF CARE CARDIAC MARKERS WERE PERFORMED ON PATIENT AT 00:53 A.M. WITH THE FOLLOWING RESULTS: TNI 1.54, CKMB >80, MYO 173 AND BNP < 5.0. PATIENT HAD FOUR PREVIOUS SERIAL LAB TROPONINS PERFORMED WHICH WERE ALL NEGATIVE (<0.15). THIS PATIENT WAS SCHEDUELD FOR A HEART CATHERTERIZATION HOWEVER, THIS DID NOT OCCUR DUE TO THE CONFLICTING RESULTS. THE CHEMISTRY SPECIMEN COLLECTED AT THE SAME TIME AS THE POINT OF CARE CARDIAC MARKERS WERE: TROPONIN <0.015, CKMB <0.5, MYO 32. INITIAL REVIEW OF SPECIMEN RESULTS DID NOT REVEAL CAUSE OF ERRONEOUS RESULTS. THE ORIGINAL SPECIMEN WAS SENT TO BIOSITE FOR FURTHER TESTING. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOSITE | TRIAGE METERPRO | NBC | INVERNESS MEDICAL | * | 45474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |