BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION®

    MDR report key: 6076192 · Received November 3, 2016

    Report

    Report Number
    2517506-2016-00351
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 3, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CFQ
    PMA / PMN Number
    K990553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT DATA PROVIDED INDICATES THAT THE CAUSE FOR THE DEPRESSED IGM RESULT IS UNKNOWN. THE REPORTED RESULT OF 4535.42 MG/DL WITH AN ASSAY RANGE/DILUTED FLAG WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SIEMENS HEADQUARTERS SUPPORT CENTER REPRESENTATIVE COMPLETED AN INVESTIGATION OF THE INCIDENT AND CONCLUDED THAT THE REPORTED RESULT WAS ACCOMPANIED WITH AN ASSAY RANGE FLAG OR ASSAY RANGE/DILUTED FLAG INDICATING THE RESULT WAS ABOVE THE ASSAY RANGE. PER THE DIMENSION RXL MAX OPERATOR'S GUIDE, THIS RESULT IS NOT REPORTABLE SINCE IT WAS ACCOMPANIED BY THE ASSAY RANGE FLAG. QC WAS WITHIN LABORATORY RANGES ON THE DATE OF TESTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCREPANT DEPRESSED IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION RXL MAX INSTRUMENT RELATIVE TO RESULTS ON AN ALTERNATE METHODOLOGY. THE RESULTS WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A HIGHER RESULT WAS OBTAINED ON THE SAME SAMPLE BY THE ALTERNATE METHODOLOGY. THERE IS AN INDICATION THAT PATIENT TREATMENT WAS DELAYED ON THE BASIS OF THE QUESTIONED DEPRESSED IGM RESULTS. A PLATELET REMOVAL TREATMENT WAS PERFORMED ONE DAY LATER ON THE BASIS OF THE HIGHER RESULT OBTAINED ON THE ALTERNATE METHODOLOGY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE QUESTIONED DEPRESSED IGM RESULT OR THE DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726823 DIMENSION® DIMENSION® IGM IMMUNOGLOBULIN M FLEX® REAGENT CARTRIDGE1500 SYSTEM CFQ SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DA7095

    Patients

    Seq Age Sex Outcome Treatment
    1