ADVIA 2400
Received Jan 21, 2010 · Event occurred Nov 23, 2009
Report 2432235-2010-00007 · MDR key 1585963
Device
Generic name
Chemistry Analyzer
Manufacturer
Siemens Healthcare Diagnostics IncModel number
ADVIA 2400Catalog number
073-A010
Lot number
NA
Product problems
- Low Test Results
Patient
63 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT IMMUNOGLOBULIN M_2 (IGM_2), RESULTS WERE OBTAINED ON AN ADVIA 2400 FOR 1 PATIENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. DUE TO THE PATIENT'S HISTORY, THE PHYSICIAN EXPECTED A RESULT OF APPROXIMATELY 30 G/L. SUBSEQUENT ELECTROPHORESIS ON THE SAMPLE YIELDED A CONFIRMATORY RESULT OF 29 G/L. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTIONS DUE TO THE DISCORDANT IGM_2 RESULTS.
Additional Manufacturer Narrative
A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE CUSTOMER SITE. THIS APPEARS TO BE A CASE OF POSSIBLE SAMPLE INTERFERENCE. NO FURTHER CONCLUSION CAN BE DRAWN AT THIS TIME.
Remedial action
- Other