FDA Adverse Event
Other
Summary report: N
DCA VANTAGE ANALYZER
MDR report key: 3071016
·
Received April 11, 2013
Report
- Report Number
- 1217157-2013-00057
- Event Type
- Other
- Date Received
- April 11, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 28, 2013
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- CGX
- PMA / PMN Number
- K071466
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT HBA1C RESULT IS UNKNOWN.
Description of Event or Problem · 1
CUSTOMER REPORTED DISCORDANT HEMOGLOBIN A1C RESULTS. A FINGER STICK ON THE DCA RESULTED IN AN 8.6 WHEREAS A REFERENCE LAB RESULT WAS 7.4. THERE WAS NO REPORT OR INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155346 | DCA VANTAGE ANALYZER | DCA VANTAGE | CGX | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 0644122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |