FDA Adverse Event
Other
Summary report: N
ADVIA 1650
MDR report key: 1240882
·
Received November 10, 2008
Report
- Report Number
- 2432235-2008-00134
- Event Type
- Other
- Date Received
- November 10, 2008
- Date of Event
- October 24, 2008
- Report Date
- October 27, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JJE
- PMA / PMN Number
- K990346
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT CALCIUM RESULTS WAS DUE TO THE CLOGGED DILUTION WASH UP DOWN SYSTEM. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A NUMBER OF DISCREPANT ELEVATED ADVIA 1650 CALCIUM RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AT THE LAB SUPERVISOR'S REQUEST AND THE INITIAL RESULTS WERE CORRECTED. THERE WAS NO PATIENT INTERVENTION OR REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT CALCIUM RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVIA 1650 | CLINICAL CHEMISTRY ANALYZER | JJE | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |