BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY XYSTEM

    MDR report key: 4917271 · Received July 15, 2015

    Report

    Report Number
    2517506-2015-00159
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DJG
    PMA / PMN Number
    K003209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS DETERMINED THAT DIMENSION URINE OPIATE SCREEN OPERATED ACCORDING TO SPECIFICATION; SIEMENS IS FILING THIS ONLY TO REPORT A PATIENT DEATH AT A SUBSEQUENT TREATMENT FACILITY. THE URINE OPIATE SCREEN DETECTS MORPHINE. ALTHOUGH HEROIN IS METABOLIZED TO MORPHINE, THE CONCENTRATION OF MORPHINE IN URINE MAY NOT BE ABOVE THE CUT-OFF CONCENTRATION (300 NG/ML) OF THE ASSAY. AS STATED IN THE INTENDED USE OF THE DIMENSION FLEX REAGENT CARTRIDGE URINE OPIATES SCREEN INSTRUCTIONS FOR USE: "OPIATES ARE ABSORBED RAPIDLY. HEROIN IS CONVERTED ALMOST IMMEDIATELY TO MORPHINE, WHICH IS EXCRETED IN URINE BOTH UNCHANGED AND AS A GLUCURONIDATED METABOLITE. EXCRETION TAKES PLACE OVER A PERIOD OF A COUPLE OF DAYS." NALOXONE WAS ADMINISTERED IN THE AMBULANCE WHICH INDICATES THAT THEY WERE FOLLOWING STANDARD PROCEDURE FOR A HEROIN OVERDOSE; ONGOING MANAGEMENT OF THE PATIENT WOULD REQUIRE TITRATION OF NALOXONE AS NEEDED TO MAINTAIN BREATHING AND CONSCIOUSNESS. ADDITIONALLY, THE DIMENSION URINE OPIATES SCREEN STATES IN THE INSTRUCTIONS FOR USE: "THE OPI METHOD PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. OTHER CHEMICAL CONFIRMATION METHODS ARE AVAILABLE. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE USED." DILUTING A URINE SAMPLE AND RUNNING THE SAMPLE AND MULTIPLYING BY THE DILUTION FACTOR IS NON-STANDARD USE WHEN THE URINE OPIATE SCREEN IS RUN IN QUALITATIVE MODE. PER THE INSTRUCTIONS FOR USE, THE DILUTION CAN ONLY BE USED IN THE SEMI-QUANTITATIVE MODE.

    Description of Event or Problem · 1

    A PATIENT WAS BROUGHT TO THE (B)(6) HOSPITAL FACILITY BY AMBULANCE WITH A DIAGNOSIS OF HEROIN OVERDOSE. THE PATIENT HAD BEEN TREATED WITH NALOXONE BY THE PARAMEDICS. THE PATIENT WAS IN CARDIAC ARREST. WHILE AT THE HOSPITAL, THE PATIENT'S URINE TESTED NEGATIVE FOR OPIATES WITH THE DIMENSION URINE OPIATES SCREEN. THE ER TRANSFERRED THE PATIENT TO ANOTHER HOSPITAL WHERE HE DIED. THERE WAS NO INDICATION THAT PATIENT TREATMENT WOULD HAVE BEEN ALTERED OR PRESCRIBED ON THE BASIS OF THE NEGATIVE OPIATES RESULT. THERE WAS NO INDICATION THAT A MEDICAL PROCEDURE OR A MEDICAL TREATMENT WAS DELAYED ON THE BASIS OF THE NEGATIVE OPIATES RESULT. THERE IS NO ALLEGATION THAT HARM TO THE PATIENT OR THE DEATH WAS DUE TO THE NEGATIVE OPIATE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461192 DIMENSION® CLINICAL CHEMISTRY XYSTEM URINE OPIATES SCREEN FLEX® REAGENT CARTRIDGE DJG SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR