FDA Adverse Event
Other
Summary report: N
ADVIA CENTAUR HBSAG ASSAY
MDR report key: 1637709
·
Received March 16, 2010
Report
- Report Number
- 1219913-2010-00033
- Event Type
- Other
- Date Received
- March 16, 2010
- Date of Event
- February 25, 2010
- Report Date
- February 26, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- LOM
- PMA / PMN Number
- P030029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A POSITIVE ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND CONFIRMED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY. THE PT WAS REDRAWN AND THE SAMPLE WAS TESTED. THE RESULTS WERE SIMILAR AND CONFIRMED WITH THE CONFIRMATORY ASSAY. THE PT HAS NOT HAD ELEVATED LIVER ENZYMES SINCE 2008. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA CENTAUR HBSAG ASSAY | HBS IMMUNOASSAY | LOM | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |