BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE

    MDR report key: 5252470 · Received November 26, 2015

    Report

    Report Number
    2517506-2015-00210
    Event Type
    Malfunction
    Date Received
    November 26, 2015
    Date of Event
    November 1, 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
    BR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE IMPRECISION WITH QC AND PATIENT SAMPLES WITH SIROLIMUS LOT EB6064 IS UNKNOWN. THE CUSTOMER MOVED TESTING TO AN ALTERNATE LOT. THE ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS.

    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 REPORTED IMPRECISION OF SIROLIMUS (SIRO) RESULTS WITH QC AND PATIENT SAMPLES WITH LOT EB6064. IT IS UNKNOWN IF THE INITIAL PATIENT RESULTS HAVE BEEN REPORTED TO PHYSICIANS. THE SAMPLES WERE REPEATED ON AN ALTERNATE LOT OF REAGENT AND THE REPEAT RESULTS WITH LOT FA6136 WERE REPORTED. IT IS NOT ALLEGED THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE IMPRECISE SIRO RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IMPRECISE SIRO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782373 DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE DIMENSION® SIROLIMUS FLEX® REAGENT CARTRIDGE NRP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW EB6064

    Patients

    Seq Age Sex Outcome Treatment
    1