BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2517506-2013-00275

    MDR report key: 3189637 · Received June 26, 2013

    Report

    Report Number
    2517506-2013-00275
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    PMA / PMN Number
    K070853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED ETOH RESULTS IS UNKNOWN. TESTING ON THE OPEN WELL STABILITY OF A RETAINED SAMPLE FROM THE SAME LOT OF FLEX(R) REAGENT CARTRIDGES AS USED BY THE CUSTOMER WAS PERFORMED IN THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE LABORATORY TO CONFIRM THE FIVE DAY CLAIM IN THE REAGENT INSTRUCTIONS FOR USE. NO INCREASE IN ETOH RECOVERY WAS OBSERVED OVER FIVE DAYS WITH OPEN WELL CONDITIONS. THE COMPLAINT WAS NOT CONFIRMED. THE IFU FOR THE ETHYL ALCOHOL FLEX REAGENT CARTRIDGES LIMITATIONS OF PROCEDURE SECTION CONTAINS THE FOLLOWING INFORMATION: ENVIRONMENTAL ETHANOL CONTAMINATION MAY RESULT IN ELEVATED ETHANOL RESULTS AND HAS BEEN SHOWN TO EFFECT OPEN WELL STABILITY.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ETHYL ALCOHOL (ETOH) RESULT WAS OBTAINED ON A PATIENT'S SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT SAMPLE WAS REPEATED WITH A NEW REAGENT FROM A PREVIOUSLY UNOPENED FLEX(R) WELL COMPARTMENT AND A NEGATIVE RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE ELEVATED ETOH RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED ETOH RESULT.

    Patients

    Seq Age Sex Outcome Treatment
    1