FDA Adverse Event
Other
Summary report: N
ADVIA 2400
MDR report key: 1585963
·
Received January 21, 2010
Report
- Report Number
- 2432235-2010-00007
- Event Type
- Other
- Date Received
- January 21, 2010
- Date of Event
- November 23, 2009
- Report Date
- November 30, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- CFN
- PMA / PMN Number
- K990346
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE CUSTOMER SITE. THIS APPEARS TO BE A CASE OF POSSIBLE SAMPLE INTERFERENCE. NO FURTHER CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
DISCORDANT IMMUNOGLOBULIN M_2 (IGM_2), RESULTS WERE OBTAINED ON AN ADVIA 2400 FOR 1 PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. DUE TO THE PATIENT'S HISTORY, THE PHYSICIAN EXPECTED A RESULT OF APPROXIMATELY 30 G/L. SUBSEQUENT ELECTROPHORESIS ON THE SAMPLE YIELDED A CONFIRMATORY RESULT OF 29 G/L. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTIONS DUE TO THE DISCORDANT IGM_2 RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA 2400 | CHEMISTRY ANALYZER | CFN | SIEMENS HEALTHCARE DIAGNOSTICS INC | ADVIA 2400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |