FDA Adverse Event
Other
Summary report: N
IMMULITE 2000 AFP
MDR report key: 1406860
·
Received March 10, 2009
Report
- Report Number
- 2017183-2008-00076
- Event Type
- Other
- Date Received
- March 10, 2009
- Date of Event
- August 19, 2008
- Report Date
- August 28, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- LOJ
- PMA / PMN Number
- K983263
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT AFP RESULTS IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
LOWER THAN EXPECTED IMMULITE AFP RESULTS WERE REPORTED BY THE ASSAY. THE TEST WAS REPEATED AND GAVE A RESULT MORE IN LINE WITH THE PATIENT'S CLINICAL PICTURE. NO PATIENT TREATMENT WAS ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, DUE TO THE DISCORDANT AFP ASSAY RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 AFP | AFP IMMUNOASSAY | LOJ | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |