BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION

    MDR report key: 8911400 · Received August 20, 2019

    Report

    Report Number
    2517506-2019-00327
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    July 30, 2019
    Report Date
    October 7, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CJW
    UDI-DI
    00842768005343
    PMA / PMN Number
    K861700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2517506-2019-00327 WAS FILED ON (B)(4) 2019. ADDITIONAL INFORMATION (B)(4) 2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) PATIENT RESULTS. THE DIMENSION EXL USES A BROMOCRESOL PURPLE (BCP) ASSAY. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE ALBUMIN METHOD, "BECAUSE OF AN ENHANCED SPECIFICITY OF BCP FOR ALBUMIN, THIS METHOD IS NOT SUBJECT TO GLOBULIN INTERFERENCE." NO PRODUCT OR SYSTEM NON-CONFORMANCE WAS IDENTIFIED BY THIS INVESTIGATION. THE CAUSE OF THIS EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) PATIENT RESULTS WERE OBTAINED ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A NEW SAMPLE WAS PROCESSED USING THE SAME INSTRUMENT AND AN ALTERNATE DIMENSION EXL 200 INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE NEW SAMPLE WAS ALSO PROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT ON THE SAME DAY AND HIGHER RESULTS WERE OBTAINED. A CORRECTED REPORT WAS ISSUED WITH THE HIGHER RESULTS. THE PATIENT WAS ADMINISTERED AN ALBUMIN INFUSION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ALBUMIN RESULTS OR DUE TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707445 DIMENSION DIMENSION® EXL¿ 200 ALBUMIN FLEX® REAGENT CARTRIDGE CJW SIEMENS HEALTHCARE DIAGNOSTICS INC. BA0059 00842768005343

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR