IMMULITE/IMMULITE 1000 CORTISOL
Received Sep 23, 2014 · Event occurred Jul 3, 2014
Report 2432235-2014-00551 · MDR key 4111371
Device
Generic name
Immulite/immulite 1000 Cortisol
Manufacturer
Siemens Healthcare Diagnostics Products LimitedModel number
IMMULITE/IMMULITE 1000 CORTISOLCatalog number
LKCO
Lot number
382
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER HAS OBSERVED HIGH BIAS RESULTS ON TWO LEVELS FOR BIORAD QUALITY CONTROL SAMPLES WHEN USING THE CORTISOL ASSAY REAGENT LOT 382 ON AN IMMULITE 1000 SYSTEM. THE BIAS WAS ALSO OBSERVED BY THE CUSTOMER FOR REAGENT LOTS 378 AND 379. THE CUSTOMER DID NOT REPORT ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON THE BIORAD QUALITY CONTROL SAMPLES.
Additional Manufacturer Narrative
SIEMENS HAS CONFIRMED THAT IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS 381, 382, AND 383 DEMONSTRATE A POSITIVE BIAS WITH PATIENT SAMPLES IN THE RANGE OF APPROXIMATELY 13% TO 40%. THE POSITIVE BIAS WAS ALSO OBSERVED IN QUALITY CONTROL MATERIALS AND MAY RESULT IN VALUES OUTSIDE THE ESTABLISHED RANGES. THE ISSUE HAS BEEN RESOLVED WITH IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS (B)(4) AND ABOVE. AN URGENT MEDICAL DEVICE RECALL UMDR2014-09-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 1111, WAS SENT TO OUS CUSTOMERS IN SEPTEMBER OF 2014. THE UMDR AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO DISCONTINUE USE OF AND DISCARD THE IMMULITE/IMMULITE 1000 CORTISOL KITS LISTED, AND TO REVIEW THE UMDR/UFSN WITH THEIR MEDICAL DIRECTOR.