IMMULITE 2000 ERYTHROPOIETIN
Received Aug 28, 2012 · Event occurred Jul 30, 2012
Report 2432235-2012-00261 · MDR key 2716385
Device
Generic name
Erythropoietin Assay
Manufacturer
Siemens Healthcare DiagnosticsModel number
IMMULITE 2000Lot number
230
Product problems
- False Reading From Device Non-Compliance
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A DISCORDANT, FALSELY ELEVATED ERYTHROPOIETIN (EPO) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT WITH LOT # 230. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RERUN TO OBTAIN THE CORRECTED RESULT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED EPO RESULT.
Additional Manufacturer Narrative
THE CUSTOMER CALLED THE TECHNICAL SOLUTIONS CENTER (TSC) ABOUT THE DISCORDANT EPO RESULT. THE CUSTOMER STATED THAT THE LABORATORY RUNS OTHER ASSAYS (SUCH AS VITAMIN B12 AND FOLATE) THAT USE THE DILUTION WELL AND THAT THERE ARE NO PROBLEMS WITH THOSE ASSAYS. BASED ON THIS, THE TSC SPECIALIST DETERMINED THAT THE INSTRUMENT DID NOT REQUIRE A FIELD SERVICE ENGINEER TO INSPECT. THE INSTRUCTIONS FOR USE (IFU) FOR THE EPO ASSAY ON THE IMMULITE 2000 INSTRUMENT DOES INDICATE THAT THE ASSAY HAS LIMITATIONS. THE IFU STATES: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH THE IMMUNOGLOBULINS INCLUDED IN THE ASSAY COMPONENTS CAUSING INTERFERENCE WITH IN VITRO IMMUNOASSAYS." THE CAUSE OF THE DISCORDANT EPO RESULT IS UNKNOWN.