FDA Adverse Event
Other
Summary report: N
AXSYM TROPONIN I ADV REAGENT
MDR report key: 762609
·
Received September 15, 2006
Report
- Report Number
- 1415939-2006-00021
- Event Type
- Other
- Date Received
- September 15, 2006
- Date of Event
- June 23, 2006
- Report Date
- August 21, 2006
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- MMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
A PHYSICIAN QUESTIONED AXSYM TROPONIN-I ADV RESULTS ON A PATIENT. THE PATIENT'S RESULTS WERE 39.67 NG/ML (IN 2006), 53 NG/ML (THE FOLLOWING MONTH) AND 37 NG/ML (THE NEXT MONTH). THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH DID NOT INDICATE ANY EVIDENCE OF A MYOCARDIAL INFARCTION. SAMPLE FROM THE PATIENT WAS SENT TO ANOTHER LABORATORY FOR TESTING (METHOD UNK) YIELDING A TROPONIN RESULT OF 0 NG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM TROPONIN I ADV REAGENT | MEIA FOR MEASUREMENT OF TROPONIN I | MMI | ABBOTT LABORATORIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | AXSYM ANALYZER LIST 7A83-01 |