IMMULITE 2000 ANDROSTENEDIONE
Received Dec 20, 2016 · Event occurred Nov 17, 2016
Report 2432235-2016-00778 · MDR key 6189519
Device
Generic name
Immulite 2000 Androstenedione
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000 ANDROSTENEDIONECatalog number
L2KAO
Lot number
349
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2016-00778 WAS FILED ON DECEMBER 20, 2016. ADDITIONAL INFORMATION (02/01/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED QUALITY CONTROL AND ADJUSTMENT DATA AND DETERMINED THAT THEY WERE UNACCEPTABLE A DAY BEFORE THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER RUNS ANDROSTENEDIONE ASSAY TWO TIMES A WEEK AND REAGENT PACKS ARE LIKELY TO REMAIN ON-BOARD TOWARDS THE END OF THE STABILITY. THE CUSTOMER HAD 2 PACKS ON-BOARD (1 FRESH AND 1 UNKNOWN) AT THE TIME THE DISCORDANT RESULTS WERE OBTAINED. THE HSC SPECIALIST STATED THAT THE REAGENT HANDLING AND/OR STORAGE MAY HAVE CAUSED THE DISCORDANT RESULTS. THE CUSTOMER CONTINUES TO PROCESS THE PATIENT SAMPLES AND QUALITY CONTROLS WITH NO FURTHER ISSUES. THE CAUSE OF THE DISCORDANT ANDROSTENEDIONE RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.
Additional Manufacturer Narrative
A SIEMENS TECHNICAL APPLICATION SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. THE TAS REPLACED THE REAGENT PACK AND THE ISSUE RESOLVED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ANDROSTENEDIONE RESULTS ON MULTIPLE PATIENT SAMPLES IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.
Description of Event or Problem
THE CUSTOMER OBTAINED DISCORDANT, FALSELY ELEVATED ANDROSTENEDIONE RESULTS ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 349. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ANDROSTENEDIONE RESULTS.