FDA Adverse Event
Other
Summary report: N
IMMULITE 2500 STAT INTACT PTH
MDR report key: 1449654
·
Received March 10, 2009
Report
- Report Number
- 2017183-2008-00074
- Event Type
- Other
- Date Received
- March 10, 2009
- Date of Event
- August 11, 2008
- Report Date
- August 28, 2008
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- CEW
- PMA / PMN Number
- K013566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT STAT INTACT PTH RESULTS ARE UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
A LOW IMMULITE 2500 STAT INTACT PTH PT SAMPLE WAS REPORTED TO THE PHYSICIAN WHO ORDERED THE SAMPLE TO BE REPEATED. UPON REPEAT, THE INTACT PTH RESULT OBTAINED WAS HIGHER THAN THE INITIAL RESULT, WHICH WAS IN ALIGNMENT WITH THE PT'S CLINICAL PICTURE. PT TREATMENT WAS ADMINISTERED BASED ON THE HIGHER RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT STAT INTACT PTH ASSAY RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2500 STAT INTACT PTH | STAT INTACT PTH IMMUNOASSAY | CEW | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | 114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |