IMMULITE 2000 3GALLERGY SPECIFIC IGE
Received Oct 19, 2017 · Event occurred Jul 3, 2017
Report 2432235-2017-00558 · MDR key 6963933
Device
Generic name
Immulite 2000 3gallergy Specific Ige
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000 3GALLERGY SPECIFIC IGELot number
453
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
88 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2017-00558 WAS FILED ON 19-OCT-2017. ADDITIONAL INFORMATION (30-NOV-2017): NO SAMPLE WAS AVAILABLE FOR IN-HOUSE TESTING. A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE EVENT DATA AND STATED THAT THE ISSUE COULD BE SITE SPECIFIC. THE CAUSE OF THE DISCORDANT, FALSELY LOW 3 GALLERGY SPECIFIC IGE RESULTS FOR CRAB AND SHRIMP ON ONE PATIENT SAMPLE IS UNKNOWN.
Additional Manufacturer Narrative
THE INITIAL MDR 2432235-2017-00558 WAS FILED ON 19-OCT-2017. THE FIRST SUPPLEMENTAL MDR 2432235-2017-00558_S1 WAS FILED ON 19-DEC-2017. ADDITIONAL INFORMATION (20-DEC-2017): THE CUSTOMER VERIFIED THAT THE ASSAY IS PERFORMING AS EXPECTED. CORRECTED INFORMATION (20-DEC-2017): CONCLUSION CODE HAS BEEN UPDATED.
Additional Manufacturer Narrative
THE CAUSE OF THE DISCORDANT, FALSELY LOW 3GALLERGY SPECIFIC IGE RESULTS FOR CRAB AND SHRIMP ON ONE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.
Description of Event or Problem
THE CUSTOMER OBTAINED DISCORDANT, FALSELY LOW 3GALLERGY SPECIFIC IGE RESULTS FOR CRAB (F23) AND SHRIMP (F24) ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING REAGENT LOT 453. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED IN AN ALTERNATE LABORATORY ON AN ALTERNATE PLATFORM, RESULTING HIGHER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CORRECTED RESULTS FROM THE ALTERNATE PLATFORM WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW 3GALLERGY SPECIFIC IGE RESULTS FOR CRAB AND SHRIMP.