FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR PSA ASSAY
MDR report key: 251210
·
Received November 18, 1999
Report
- Report Number
- 1219913-1999-00002
- Event Type
- Other
- Date Received
- November 18, 1999
- Date of Event
- July 23, 1999
- Report Date
- July 27, 1999
- Manufacturer
- BAYER DIAGNOSTICS
- Product Code
- LTJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON OCTOBER 27, 1999, BAYER DIAGNOSTICS REC'D A REPORT REGARDING ITS PSA2 ASSAY. A TEST RESULT FOR PROSTATE SPECIFIC ANTIGEN (PSA) IN JULY, 1999 WAS REPORTED ON THE ADVIA CENTAUR AS 110 NG/ML. AS A RESULT OF THIS VALUE, THE HEALTH CARE PROVIDER ELECTED TO PERFORM A BIOPSY. FINDINGS APPEARED TO BE NEGATIVE AND NO COMPLAINTS FROM THE PT FOR PROSTATE DISTRESS WERE REPORTED. A SAMPLE WAS REDRAWN ON OCT. 27, 1999 AND REPORTED AS GREATER THAN 155. AUTODILUTION OF THE SAMPLE WAS PERFORMED, RECALCULATED RESULTS WERE REPORTED AS 2.5 AND 3.0 NG/ML, RESPECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR PSA ASSAY | PSA IMMUNOASSAY | LTJ | BAYER DIAGNOSTICS | * | 89CD87 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |