BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3884635 · Received June 19, 2014

    Report

    Report Number
    2517506-2014-00063
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    June 10, 2006
    Report Date
    May 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JIF
    PMA / PMN Number
    K944093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. WAS INFORMED ON (B)(4) 2014 OF AN INCIDENT WITH A PATIENT HOSPITALIZED IN (B)(6) 2006. EXAMINATION OF SIEMENS COMPLAINT RECORDS FOR THE 2006 PERIOD DOES NOT INDICATE ANY COMPLAINTS FILED BY THE DOKKYO ACCOUNT ON AMON IN 2006. SIEMENS HAS INQUIRED BUT HAS NOT BEEN PROVIDED WITH INFORMATION NECESSARY TO EVALUATE THE COMPLAINT INCLUDING: -LOT NUMBER OF AMON REAGENT IN USE AT TIME OF TESTING. -AGE OF THE PATIENT. -DETAILS ON OTHER TESTING (BLOOD OR OTHER DIAGNOSTIC PROCEDURES) PERFORMED CONCURRENTLY. -SPECIMEN HANDLING, AGE, AND STORAGE PRIOR TO TESTING. INSUFFICIENT INFORMATION HAS BEEN PROVIDED TO HELP DETERMINE IF THE RESULTS OBTAINED COULD HAVE CONTRIBUTED TO THE PATIENT DEATH. WE HAVE NO INFORMATION TO SUGGEST THAT QC TESTING WAS NOT WITHIN ACCEPTABLE LABORATORY RANGES IN THE TIME PERIOD OF THE TESTING OR THAT THERE WERE ANY RECORDED REAGENT OR INSTRUMENT MALFUNCTIONS. PER REFERENCE: TIETZ TEXTBOOK OF CLINICAL CHEMISTRY, 2ND EDITION; C. A. BURTIS, E. R. ASHWOOD; P.642. CITRULLINEMIA IS KNOWN TO PROMOTE EXCESS AMMONIA LEVELS IN BLOOD. SIEMENS IS CONTINUING TO INVESTIGATE THE INCIDENT.

    Description of Event or Problem · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. WAS INFORMED ON (B)(4) 2014 OF AN INCIDENT WITH A PATIENT HOSPITALIZED IN (B)(6) 2006. THE COMPLAINT ALLEGES THAT THE AMMONIA FLEX(R) REAGENT CARTRIDGE (AMON, DF19) RESULTS OBTAINED ON A PATIENT ON THE SIEMENS DIMENSION RXL MAX INSTRUMENT WERE NOT CORRECT. IT IS ALLEGED THAT THE LOW AMON RESULTS ON THE SIEMENS INSTRUMENT CONTRIBUTED TO INAPPROPRIATE TREATMENT DECISIONS. THE PATIENT DIED (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360505 DIMENSION® CLINICAL CHEMISTRY SYSTEM AMMONIA FLEX® REAGENT CARTRIDGE JIF SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Death