FDA Adverse Event
Malfunction
Summary report: N
DIMENSION® CLINICAL CHEMISTRY SYSTEM
MDR report key: 1983518
·
Received February 10, 2011
Report
- Report Number
- 1226181-2011-00008
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
- Product Code
- MMI
- PMA / PMN Number
- K944093
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TROPONIN I RESULT WAS R2 PROBE MALFUNCTION. SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SUPPORT CENTER DIRECTED THE CUSTOMER TO REPLACEMENT OF THE R2 PROBE AND OTHER MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A FALSELY ELEVATED TROPONIN I RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A NEGATIVE RESULT WAS OBTAINED. THE PATIENT WAS ADMITTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIMENSION® CLINICAL CHEMISTRY SYSTEM | CLINICAL CHEMISTRY SYSTEM | MMI | SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD | RXLMAXRHQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |