IMMULITE 2000
Received Mar 4, 2013 · Event occurred Jan 29, 2013
Report 2247117-2013-00023 · MDR key 2988263
Device
Generic name
Immulite 2000
Manufacturer
Siemens Healthcare DiagnosticsModel number
IMMULITE 2000Catalog number
030002
Product problems
- Imprecision
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IMPRECISION WAS OBSERVED ON FOUR PATIENT SAMPLES FOR INSULIN-LIKE GROWTH FACTOR (IGF-1) ON AN IMMULITE 2000 INSTRUMENT. IT IS UNKNOWN WHETHER PATIENT SAMPLES WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION ON THE FOUR PATIENT SAMPLES.
Additional Manufacturer Narrative
A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA, AND COULD NOT FIND AN INSTRUMENT MALFUNCTION. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA, AND ALSO COULD NOT FIND AN INSTRUMENT MALFUNCTION. THE FSE PERFORMED PREVENTIVE MAINTENANCE AND PROACTIVELY REPLACED SPARE PARTS. THE CAUSE OF THE IGF-1 IMPRECISION IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.