FDA Adverse Event
Other
Summary report: N
IMMULITE HCG ASSAY
MDR report key: 2803288
·
Received June 1, 2009
Report
- Report Number
- 2017183-2009-00046
- Event Type
- Other
- Date Received
- June 1, 2009
- Date of Event
- April 13, 2009
- Report Date
- April 16, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- DHA
- PMA / PMN Number
- K990222
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT HCG RESULT. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
A POSITIVE IMMULITE HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE ORIGINAL SAMPLE WAS RETESTED AND THE HCG RESULT WAS STILL POSITIVE. AN ULTRA SOUND AND URINE DIPSTICK CONFIRMED NO PREGNANCY. PATIENT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE HCG ASSAY | HCG IMMUNOASSAY | DHA | SIEMENS HEALTHCARE DIAGNOSTICS | NA | 333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |