BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 3203002 · Received July 2, 2013

    Report

    Report Number
    2247117-2013-00064
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    P010053/S007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (09/26/2013): A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST CONTACTED THE CUSTOMER AND PROVIDED THE CUSTOMER WITH AN EXPLANATION REGARDING THE EXTENDED AND STANDARD CLASSIFICATION SYSTEMS FOR ALLERGENS. THE EXTENDED CLASSIFICATION SYSTEM WAS DEVELOPED IN RESPONSE TO THE AVAILABILITY OF HIGHER SENSITIVITY METHODS AND IS A PRODUCT OF THE MODIFIED RAST (MRAST) SYSTEMS. SINCE MRAST WERE DETERMINED TO BE MORE SENSITIVE THAN THE RAST, THE CUTOFF VALUE FOR THE EXTENDED SCORING METHOD FOR CLASS I WERE LOWER IN TERMS OF KU/L THAN IN THE STANDARD SCORING METHOD. BASED ON THE RESULTS FOR FP7 (FOOD PANEL) AND THE INSTRUCTIONS FOR USE (IFU), SPECIFIC IGE RESULTS THAT ARE GREATER THAN 0.10 KU/L, USING BOTH EXTENDED AND STANDARD CLASSIFICATION SYSTEMS WOULD BE CONSIDERED VERY LOW, EXHIBITING A MODEST RESPONSE. RESULTS LOWER THAN 0.10 ARE CONSIDERED NEGATIVE OR NOT DETECTABLE. RESULTS THAT ARE GREATER THAN 0.10 KU/L SHOULD BE TESTED ON THE INDIVIDUAL ALLERGENS. THE REGION AND THE CUSTOMER WERE SATISFIED WITH THE EXPLANATION OF THE RESULTS AND CONFIRMED THAT NO FURTHER ASSISTANCE WAS REQUIRED. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS TECHNICAL SOLUTIONS CENTER. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE CAUSE OF THE LOW FP7 IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    LOW ALLERGEN RESULTS FOR FP7 ALLERGEN (CLASS 0/1) WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE WAS REPEATED TWO TIMES WITH COMPARABLE RESULTS ON THE IMMULITE 2000. THE RESULTS ON FP1(EGG WHITE) AND FP2 (MILK) ALLERGENS, BOTH OF WHICH ARE PART OF THE FP7 ALLERGEN WERE HIGHER AND TESTED TWICE. THE FP1 AND FP2 RESULTS WERE CONFIRMED ON AN ALTERNATE PLATFORM AND FOUND TO BE CLINICALLY SIMILAR TO THE IMMULITE XPI 2000 FP1 AND FP2 RESULTS. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ALLERGEN F7 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302999 IMMULITE 2000 XPI IMMULITE 2000 XPI JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI

    Patients

    Seq Age Sex Outcome Treatment
    1