IMMULITE 2000 XPI - SPE
Received Jul 11, 2019 · Event occurred Jun 17, 2019
Report 2432235-2019-00235 · MDR key 8781310
Device
Generic name
Immulite 2000 Xpi - Spe
Manufacturer
Siemens Healthcare Diagnostics Products, LimitedModel number
IMMULITE 2000 XPI - SPECatalog number
F17L4
Lot number
603
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT THEY OBTAINED DISCORDANT, A FALSELY NEGATIVE F17 RESULT ON AN IMMULITE 2000 XPI INSTRUMENT. THE CAUSE FOR THE DISCORDANT, FALSELY NEGATIVE RESULT FOR THE F17 LOT 603 ON A SINGLE PATIENT SAMPLE IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDR 2432235-2019-00234 WAS FILED FOR THE SAME EVENT.
Description of Event or Problem
A DISCORDANT, FALSELY NEGATIVE RESULT WAS OBTAINED FOR 3GALLERGY SPECIFIC IGE (SPE) WITH F17 HAZELNUT SPECIFIC ALLERGEN ON A SINGLE PATIENT SAMPLE USING AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS DISCORDANT AND REPORTED TO THE PHYSICIAN(S). REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE VIA AN ALTERNATE NON-SIEMENS METHOD RESULTING POSITIVE AND AS EXPECTED. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT F17 RESULT.
Additional Manufacturer Narrative
SIEMENS FILED THE INITIAL MDR 2432235-2019-00235 ON 11-JUL-2019. ADDITIONAL INFORMATION (B)(6) 2019): THE CUSTOMER PROVIDED FOUR SAMPLES TO SIEMENS FOR IN HOUSE TESTING. THE SAMPLES WERE TESTED USING HAZELNUT ALLERGEN LOT 603, AND THE RESULTS WERE COMPARED TO RESULTS OBTAINED ON AN ALTERNATE PLATFORM. THE RESULT ON THE IMMULITE 2000 WAS NEGATIVE FOR HAZELNUT BUT RESULTED POSITIVE ON THE ALTERNATE PLATFORM THUS REPRODUCING THE CUSTOMER'S OBSERVATIONS. SIEMENS IS INVESTIGATING THE ISSUE. SECTION H6 METHOD CODE WAS UPDATED. MDR 2432235-2019-00234_S1 WAS FILED FOR THE SAME EVENT.
Additional Manufacturer Narrative
SIEMENS FILED THE INITIAL MDR 2432235-2019-00235 ON (B)(6)2019. SIEMENS FILED THE SUPPLEMENTAL MDR 2432235-2019-00235_S1 ON (B)(6) 2019. ADDITIONAL INFORMATION (B)(6) 2019): SIEMENS INTERNAL INVESTIGATION HAS DETERMINED THAT THE IMMULITE 2000 3GALLERGY SPECIFIC IGE (SPE) ALLERGENS AND IMMULITE 2000 3GALLERGY MIXED ALLERGEN PANELS ARE MEETING THE SENSITIVITY PERFORMANCE CLAIMS DETAILED IN THE IMMULITE 2000/2000XPI 3GALLERGY SPECIFIC IGE (SPE) UNIVERSAL KIT INSTRUCTIONS FOR USE (IFU) THEREFORE A PRODUCT PROBLEM HAS NOT BEEN CONFIRMED. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. SECTION H6 (RESULTS AND CONCLUSION CODES) AND SECTION H10 WERE UPDATED. MDR 2432235-2019-00234_S2 WAS FILED FOR THE SAME EVENT.