IMMULITE 1000, PROGESTERONE
Received Jun 24, 2008 · Event occurred Mar 12, 2008
Report 2017183-2008-00022 · MDR key 1066026
Device
Generic name
Immunoassay System
Manufacturer
Siemens Healthcare DiagnosticsModel number
NACatalog number
LKPG
Lot number
321
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ELEVATED IMMULITE 1000 PROGESTERONE RESULTS WERE REPORTED TO THE PHYSICIAN ON TWO PTS SAMPLES. THE PHYSICIAN QUESTIONED THE RESULTS BECAUSE THE PROGESTERONE VALUES WERE ELEVATED RELATIVE TO THE PT'S ESTRADIOL LEVELS. BOTH PT SAMPLES WERE RETESTED WITH ANOTHER PROGESTERONE ASSAY AND THE RESULTS WERE LOWER. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.
Additional Manufacturer Narrative
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 PROGESTERONE RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Other