FDA Adverse Event
Other
Summary report: N
ACCESS 2 IMMUNOASSAY SYSTEM
MDR report key: 713166
·
Received May 10, 2006
Report
- Report Number
- 2122870-2006-00108
- Event Type
- Other
- Date Received
- May 10, 2006
- Date of Event
- April 18, 2006
- Report Date
- May 10, 2006
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ERRONEOUSLY ELEVATED TROPONIN (ACCU TNL) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. AN INITIAL WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. ON THE SAME DAY, THE PT ORIGINAL SAMPLE WAS RE-TESTED FOR ACCU TNL. THE REPEATED ACCU TNL RESULT WAS 0.03NG/ML. THE CUSTOMER DID NOT RECEIVED ANY REPORT OF PT INJURY REQUIRING MED INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS 2 IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJJ | BECKMAN COULTER, INC. | ACCESS2 IMMUNOASSAY SYSTEM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |