BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE

    MDR report key: 5419932 · Received February 9, 2016

    Report

    Report Number
    2517506-2016-00011
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    May 5, 2015
    Report Date
    February 2, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    NRP
    PMA / PMN Number
    K081857
    Removal / Correction Number
    2517506-02/12/2016-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS RECEIVED CUSTOMER COMPLAINTS FOR DIMENSION SIROLIMUS (SIRO) LOT EB6064. THE COMPLAINTS WERE RELATED TO QC SHIFTS AND IMPRECISION. SIEMENS HEALTHCARE DIAGNOSTICS CONDUCTED AN INVESTIGATION ON THE ON BOARD STABILITY FOR DIMENSION SIRO LOT EB6064. INVESTIGATION DETERMINED THAT DIMENSION SIRO LOT EB6064 DOES NOT MEET THE OPEN WELL STABILITY CLAIM OF TWO DAYS. INTERNAL TESTING HAS SHOWN BIASES RANGING FROM -82% TO +123% ON A POOLED SAMPLE WITH A SIROLIMUS CONCENTRATION O 8.7 NG/ML [9.5 MMOL/L] WHEN TESTED ON SUBSEQUENT DAYS OF THE TWO DAY OPEN WELL STABILITY PERIOD. RESULTS ARE UNAFFECTED AT THE START OF THE OPEN WELL STABILITY PERIOD. QUALITY CONTROL IS LIKELY TO CATCH THE ISSUE ON SUBSEQUENT DAYS OF THE OPEN WELL STABILITY CLAIM. SIEMENS HEALTHCARE DIAGNOSTICS ISSUED AN URGENT MEDICAL DEVICE RECALL COMMUNICATION DC-16-01.B.US DATED FEBRUARY, 2016 INSTRUCTING CUSTOMERS TO DISCONTINUE USE AND DISCARD ANY REMAINING INVENTORY OF THE AFFECTED LOT AND TO CONTACT SIEMENS HEALTHCARE FOR REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED THAT SIROLIMUS (SIRO) RESULTS ARE DISCREPANT WHEN REAGENT HAS BEEN HYDRATED FOR A DAY OR MORE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT SIRO RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT SIRO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79499 DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE DIMENSION® SIRO NRP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB6064

    Patients

    Seq Age Sex Outcome Treatment
    1