FDA Adverse Event
Other
Summary report: N
IMMULITE 2000 XPI CALCITONIN
MDR report key: 1728315
·
Received June 15, 2010
Report
- Report Number
- 2017183-2010-00027
- Event Type
- Other
- Date Received
- June 15, 2010
- Date of Event
- May 12, 2010
- Report Date
- May 25, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JKR
- PMA / PMN Number
- K023304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE AND PERFORMED A SYSTEM EVAL. THE FSE WAS NOT ABLE TO DETERMINE THE CAUSE FOR THE DISCORDANT LOW CALCITONIN RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECS.
Description of Event or Problem · 1
A DISCORDANT LOW IMMULITE 2000 XPI CALCITONIN RESULT WAS OBTAINED ON A PT SAMPLE. THE CUSTOMER PERFORMED REPEAT CALCITONIN TESTING AND THE RESULT WAS ELEVATED. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW CALCITONIN ASSAY RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 XPI CALCITONIN | CALCITONIN IMMUNOASSAY | JKR | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |