FDA Adverse Event
Other
Summary report: N
DIMENSION CLINICAL CHEMISTRY SYSTEM
MDR report key: 1221806
·
Received November 3, 2008
Report
- Report Number
- 2517506-2008-00099
- Event Type
- Other
- Date Received
- November 3, 2008
- Date of Event
- September 23, 2008
- Report Date
- October 28, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, INC
- Product Code
- MTF
- PMA / PMN Number
- P0000021
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TPSA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A FALSELY ELEVATED TPSA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED BY ALTERNATE METHODOLOGY AND A NEGATIVE RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TPSA RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIMENSION CLINICAL CHEMISTRY SYSTEM | TPSA FLEX REAGENT CARTRIDGE | MTF | SIEMENS HEALTHCARE DIAGNOSTICS, INC | NA | EB9184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |