IMMULITE 2000
Received Apr 20, 2015 · Event occurred Mar 20, 2015
Report 2247117-2015-00024 · MDR key 4708614
Device
Generic name
Immulite 2000
Manufacturer
Siemens Healtchcare Diagnostics IncModel number
IMMULITE 2000Catalog number
30002
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DID NOT FIND AN INSTRUMENT MALFUNCTION. QUALITY CONTROLS AND CALIBRATIONS WERE WITHIN RANGE ON THE DAY OF THE EVENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW NT-PROBNP RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT, FALSELY LOW N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NT-PROBNP) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED IN DUPLICATE ON THE SAME INSTRUMENT, RESULTING HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NT-PROBNP RESULTS.