BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE® 2000 3GALLERGY SPECIFIC IGE

    MDR report key: 20905172 · Received December 11, 2024

    Report

    Report Number
    1219913-2024-00496
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 25, 2024
    Report Date
    February 14, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    DHB
    UDI-DI
    000630414962269
    PMA / PMN Number
    K101572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT LOW 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT RESULTS THAT WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. QUALITY CONTROL (QC) LEVEL 1 WAS OBSERVED OUT OF RANGE. QC LEVEL 2 WAS IN RANGE. ADDITIONALLY, THE ADJUSTMENT HAD AN INTERCEPT HIGHER THAN THE GUIDE. THE LIMITATIONS SECTION OF THE IMMULITE 2000 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT INSTRUCTIONS FOR USE (IFU) STATES: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THIS OUS PRODUCT (CATALOG NUMBER: 10380875, AS LISTED IN D4) IS ASSOCIATED WITH SIMILAR PRODUCT IN THE UNITED STATES: CATALOG NUMBER: 10708840 / PREMARKET APPROVAL (PMA)# K101572.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2024-00496 ON 11-DEC-2024. ADDITIONAL INFORMATION 14-FEB-2025: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: THE CUSTOMER REPORTED THE OBSERVATION OF AN INTERCEPT OUTSIDE OF CRITERIA, QC LEVEL 1 HIGH OUT OF RANGE, AND 3 PATIENTS INITIALLY RESULTED AS <0.1 KU/L AND ARE HIGHER ON REPEAT WITH IMMULITE 2000 3GALLERGY SPECIFIC IGE (SPE) KIT LOT 145. SIEMENS REVIEWED INTERNAL BOX AND WHISKER (B&W) DATA FOR QUALITY CONTROLS. THE B&W DATA IS WITHIN SIEMENS INSTRUCTIONS FOR USE (IFU) RANGE. TO EXCLUDE AN ISSUE WITH THE INSTRUMENT REGARDING THE DISCORDANT RESULTS, INSTRUMENT FILES WERE REQUESTED, BUT NOT RECEIVED. FURTHER EVALUATION REGARDING THE DISCORDANT RESULTS WAS NOT POSSIBLE. THE CUSTOMER USED FRESH SPE KIT LOT 145 AND FRESH CONTROLS AND INTERCEPTS AND QC ARE IN RANGE AND THE CUSTOMER IS NOW SATISFIED WITH ASSAY PERFORMANCE. THE ISSUE IS RESOLVED WITH ROUTINE TROUBLESHOOTING USING FRESH REAGENTS AND FRESH QC MATERIAL. THE CUSTOMER IS OPERATIONAL AND SATISFIED WITH THE PERFORMANCE. THE IMMULITE 2000 3GALLERGY SPECIFIC IGE (SPE) KIT LOT 145 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT LOW 3GALLERGY¿ SPECIFIC IGE UNIVERSAL KIT RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL RESULTS. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429335 IMMULITE® 2000 3GALLERGY SPECIFIC IGE SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL DHB SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 145 000630414962269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown