FDA Adverse Event
Other
Summary report: N
DIMENSION CLINICAL CHEMISTRY SYSTEM
MDR report key: 1289477
·
Received January 13, 2009
Report
- Report Number
- 2517506-2009-00003
- Event Type
- Other
- Date Received
- January 13, 2009
- Date of Event
- December 29, 2008
- Report Date
- December 30, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Product Code
- CIC
- PMA / PMN Number
- K860021
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CALCIUM RESULT WAS SHORT SAMPLING DUE TO USER ERROR OF RUNNING A PRIMARY TUBE AS A SAMPLE CUP. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A NORMAL RESULT WAS OBTAINED. THE PATIENT WAS TREATED WITH INTRAVENOUS 10% CALCIUM GLUCONATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIMENSION CLINICAL CHEMISTRY SYSTEM | CA FLEX REAGENT CARTRIDGE | CIC | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | NA | DA9206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |