BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1698873 · Received May 26, 2010

    Report

    Report Number
    1823260-2010-03192
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 26, 2010
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER STATED THEY HAD ERRONEOUS RESULTS FOR MULTIPLE TESTS AND PROVIDED DATA FOR ONE PATIENT SAMPLE. THE INITIAL TOTAL PROTEIN RESULT WAS 2.5 G/DL AND WAS REPORTED. THE PHYSICIAN NOTIFIED THE LAB OF THE ERRONEOUS RESULT AND ON (B) (6) 2010, THE SAMPLE WAS PULLED AND REPEATED. THE REPEAT RESULT WAS 7.5 G/DL. THE USER STATED, THE PHYSICIAN WAS ABLE TO VIEW THE ERRONEOUS RESULT ONLINE, BUT KNEW THE VALUE WAS NOT CORRECT AND DID NOT TREAT THE PATIENT. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DAMAGED REAGENT R2 CAROUSEL AND MULTIPLE R2 REAGENT BOTTLES WERE LOOSE IN THE CAROUSEL AND WERE SHIFTING AROUND. HE REPLACED AND ADJUSTED THE CAROUSEL. TO VERIFY THE ANALYZER OPERATION, THE USER PERFORMED CALIBRATION AND QC WITH ALL RESULTS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JJE HITACHI HIGH TECH. CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1