BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE/IMMULITE 1000 CORTISOL

    MDR report key: 4111371 · Received September 23, 2014

    Report

    Report Number
    2432235-2014-00551
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
    Product Code
    CGR
    PMA / PMN Number
    K931409
    Removal / Correction Number
    2432235-09/22/14-003R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONFIRMED THAT IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS 381, 382, AND 383 DEMONSTRATE A POSITIVE BIAS WITH PATIENT SAMPLES IN THE RANGE OF APPROXIMATELY 13% TO 40%. THE POSITIVE BIAS WAS ALSO OBSERVED IN QUALITY CONTROL MATERIALS AND MAY RESULT IN VALUES OUTSIDE THE ESTABLISHED RANGES. THE ISSUE HAS BEEN RESOLVED WITH IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS (B)(4) AND ABOVE. AN URGENT MEDICAL DEVICE RECALL UMDR2014-09-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 1111, WAS SENT TO OUS CUSTOMERS IN SEPTEMBER OF 2014. THE UMDR AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO DISCONTINUE USE OF AND DISCARD THE IMMULITE/IMMULITE 1000 CORTISOL KITS LISTED, AND TO REVIEW THE UMDR/UFSN WITH THEIR MEDICAL DIRECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED HIGH BIAS RESULTS ON TWO LEVELS FOR BIORAD QUALITY CONTROL SAMPLES WHEN USING THE CORTISOL ASSAY REAGENT LOT 382 ON AN IMMULITE 1000 SYSTEM. THE BIAS WAS ALSO OBSERVED BY THE CUSTOMER FOR REAGENT LOTS 378 AND 379. THE CUSTOMER DID NOT REPORT ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON THE BIORAD QUALITY CONTROL SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590396 IMMULITE/IMMULITE 1000 CORTISOL IMMULITE/IMMULITE 1000 CORTISOL CGR SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED IMMULITE/IMMULITE 1000 CORTISOL 382

    Patients

    Seq Age Sex Outcome Treatment
    1