IMMULITE 2000 XPI - SPE

Additional Manufacturer Narrative

MDR 2432235-2019-00201 WAS FILED ON 7-JUN-2019. SUPPLEMENTAL MDR 2432235-2019-00201-S1 WAS FILED ON 20-JUN-2019. SUPPLEMENTAL MDR 2432235-2019-00201-S2 WAS FILED ON 30-JUL-2019. ADDITIONAL INFORMATION (30-SEP-2019): SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REVIEWED DATA PROVIDED BY THE CUSTOMER AND REQUESTED THE ADDITIONAL 4 PATIENT SAMPLES FOR INTERNAL INVESTIGATION. INTERNAL TESTING USING IMMULITE 2000 F17 ALLERGEN LOT: 603, AN ALTERNATE ALLERGY TESTING PLATFORM, AND WESTERN BLOT WERE PERFORMED BY SIEMENS SITE ON THE 4 PATIENT SAMPLES PROVIDED BY THE CUSTOMER. THE ADDITIONAL TESTING WAS DIRECTED AT THE F17 EXTRACT, BIOTINYLATED F17 EXTRACT, AND COR 1 MOLECULAR PROTEINS. IMMULITE 2000 3GALLERGY F17 ALLERGEN LOT: 603 RESULTED 0.10 KU/L; WHILE THE ALTERNATE ALLERGY TESTING PLATFORM AND WESTERN BLOT INDICATED A REACTION TO F17 ON ALL 4 PATIENT SAMPLES. SIEMENS HAS STOPPED SHIPPING THE IMMULITE 2000/IMMULITE 2000 XPI 3GALLERGY SPECIFIC IGE F17 (HAZELNUT) ALLERGEN LOT: 602 AND 603. NO OTHER ISSUES HAVE BEEN REPORTED BY THE CUSTOMER. SECTION H10 IS UPDATED TO REFLECT THE ADDITIONAL INFORMATION. MDR 2432235-2019-00200-S3 WAS FILED FOR THE SAME EVENT.

Additional Manufacturer Narrative

FOR THE IMMULITE 2000 XPI - SPE LOT 717 - F17 LOT 602 ASSAY DESCRIBED LOT 602 IS THE LIGAND-LABELED ALLERGEN PANEL IN LIQUID PHASE THAT IS NOT SUPPLIED IN THE SPE LOT 717 KIT BUT IS REQUIRED FOR THE RUN. FOR THE IMMULITE 2000 XPI - SPE LOT 717 - F17 LOT 603 ASSAY DESCRIBED LOT 603 IS THE LIGAND-LABELED ALLERGEN PANEL IN LIQUID PHASE THAT IS NOT SUPPLIED IN THE SPE LOT 717 KIT BUT IS REQUIRED FOR THE RUN. THE CAUSE OF THE DISCORDANT, FALSELY LOW RESULT FOR SPE LOT 717 WITH F17 LOT 603 ON A SINGLE PATIENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDR 2432235-2019-00200 WAS FILED FOR THE SAME EVENT FOR IMMULITE 2000 XPI - SPE LOT 717 - F17 LOT 602.

Description of Event or Problem

DISCORDANT, FALSELY LOW RESULTS WERE OBTAINED FOR 3GALLERGY SPECIFIC IGE (SPE) WITH F17 HAZELNUT SPECIFIC ALLERGEN (F17) ON A SINGLE PATIENT. THE INITIAL RESULT WAS DISCORDANT AND REPORTED TO THE PHYSICIAN(S). A FIRST REPEAT RESULT WAS ALSO DISCORDANT USING A DIFFERENT F17 REAGENT KIT LOT AND REPORTED TO THE PHYSICIAN(S). A SECOND REPEAT RESULT WAS CORRECT VIA AN ALTERNATE NON-SIEMENS METHOD AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SPE RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2019-00200 ON 7-JUN-2019. ADDITIONAL INFORMATION (18-JUL-2019): THE PATIENT HAS DEVELOPED AN ANAPHYLACTIC REACTION DURING A SKIN PRICK-TEST WITH HAZELNUT EXTRACT WHILE UNDER THE CARE OF A PHYSICIAN. THIS MEDICAL PROCEDURE (SKIN PRICK-TEST) WAS INDICATED BECAUSE OF THE NEGATIVE F17 (HAZELNUT) RESULT THAT LATER APPEARED TO BE FALSE NEGATIVE. ADDITIONAL INFORMATION (19-JUL-2019): THE CUSTOMER ALLEGED THAT 15 MINUTES AFTER SKIN PRICK- TEST THE PATIENT DEVELOPED NON-STOP COUGHING, RHINOCONJUNCTIVITIS, AND BRONCHOSPASTIC AUSCULATION. THE CUSTOMER ALLEGED THE EVENT DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE OF THE PATIENT. THE PATIENT RECEIVED AERIUS (DESLORATADINE) 2.5 MG AND EPINEPHRIN 0.15 MG ON WORSENING OF THE SYMPTOMS. AFTER 1 HOUR, THE PATIENT DEVELOPED ITCHING AND RED SKIN ALSO FROM UNPICKED ARM AND BUTTOCKS, MORE ITCHING, THEN NOW NO MORE LUNG COMPLAINTS. THE PATIENT WAS ADMINISTERED ANOTHER 2.5 MG AERIUS (DESLORATADINE). SIEMENS IS INVESTIGATING THE ISSUE.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR (B)(4) ON(B)(6)2019 . ADDITIONAL INFORMATION (26/DEC-2019): ALL IN-DATE LOTS OF THE IMMULITE 2000 3GALLERGY HAZELNUT SPECIFIC ALLERGEN (F17) AND HAZELNUT-CONTAINING FOOD PANELS, FOOD PANEL 1 (FP1), FOOD PANEL 24 (FP24), AND FOOD PANEL 27 (FP27), WERE TESTED TO DETERMINE WHETHER RESULTS ARE CONSISTENT WITH CLINICAL INFORMATION AND/OR ALTERNATE METHOD. FALSE NEGATIVE RESULTS WERE OBSERVED IN A VERY LIMITED SUBSET OF PATIENT SAMPLES WITH IMMULITE 2000 F17 HAZELNUT SPECIFIC ALLERGEN (F17) LOTS 602 AND 603, AND WITH IMMULITE 2000 MIXED ALLERGEN FOOD PANEL 27 (FP27). TESTING CARRIED OUT ON OTHER SAMPLE POPULATIONS AND THEN COMPARED TO F17 HAZELNUT SPECIFIC ALLERGEN AND PANELS WHICH CONTAIN HAZELNUT, FP1, FP24 AND FP27 HAS SHOWN GOOD AGREEMENT. SIEMENS INTERNAL INVESTIGATION HAS DETERMINED THAT THE IMMULITE 2000 3GALLERGY SPECIFIC ALLERGENS AND IMMULITE 2000 3GALLERGY MIXED ALLERGEN PANELS ARE MEETING THE SENSITIVITY PERFORMANCE CLAIMS DETAILED IN THE IMMULITE 2000/2000XPI 3GALLERGY SPECIFIC IGE UNIVERSAL KIT INSTRUCTIONS FOR USE (IFU) THEREFORE A PRODUCT PROBLEM HAS NOT BEEN CONFIRMED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 2432235-2019-00200-S4 WAS FILED FOR THE SAME EVENT

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2019-00201 ON 7-JUN-2019. ADDITIONAL INFORMATION (21-MAY-2019): THE CUSTOMER RE-TESTED 9 SAMPLES THAT RESULTED BETWEEN 0 AND 0.35 KU/L WITH 3GALLERGY SPECIFIC IGE (SPE) WITH F17 HAZELNUT SPECIFIC ALLERGEN (IMMULITE 2000 XPI - SPE - F17) WITH THE ALTERNATE NON-SIEMENS METHOD. FOUR SAMPLES RESULT WITH NEGATIVE RESULTS ON IMMULITE 2000 XPI - SPE - F17 WERE FOUND POSITIVE USING ALTERNATE NON-SIEMENS METHOD. SECTIONS RELEVANT TESTS/LABORATORY DATA AND OTHER RELEVANT HISTORY WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION.