FDA Adverse Event
Malfunction
Summary report: N
RAPIDCHEM 744
MDR report key: 3750815
·
Received April 15, 2014
Report
- Report Number
- 1217157-2014-00058
- Event Type
- Malfunction
- Date Received
- April 15, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 20, 2014
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS
- Product Code
- CGZ
- PMA / PMN Number
- K000926
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE FOR THE DISCORDANT SODIUM(NA) AND CHLORIDE(CL) RESULTS IS UNKNOWN.
Description of Event or Problem · 1
CUSTOMER REPORTED ERRONEOUS SODIUM(NA) AND CHLORIDE(CL) RESULTS FOR PATIENT AND QUALITY CONTROL SAMPLES WITH REFERENCE ELECTRODE. CUSTOMER INDICATED THAT NO PATIENT RESULTS WERE REPORTED AND NO PATIENT TREATMENTS WERE EFFECTED WHEN QUALITY CONTROL RESULTS WERE OUT OF RANGE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229356 | RAPIDCHEM 744 | RAPIDCHEM 744 | CGZ | SIEMENS HEALTHCARE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |