BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 7320538 · Received March 7, 2018

    Report

    Report Number
    1823260-2018-00688
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 12, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE RINSE UNIT WAS DRIPPING AND THE VACUUM LINE WAS NOT ASPIRATING SUFFICIENTLY. HE REMOVED AND REPAIRED THE RINSE UNIT, REPLACED THE NOZZLE AND RINSE STATION TUBING, AND INSTALLED A PREVENTATIVE MAINTENANCE KIT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE CREATININE AND HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDL) RESULTS ON THE MODULAR ANALYTICS P-MODULE FOR MULTIPLE PATIENT SAMPLES. OF THE DATA PROVIDED, THERE WERE ERRONEOUS RESULTS FOR 8 PATIENT SAMPLES. THERE WERE NO ERRONEOUS RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CREATININE R1 REAGENT LOT NUMBER WAS 281246 AND THE R3 REAGENT LOT NUMBER WAS 283351. THE EXPIRATION DATE WAS NOT PROVIDED. THE HDL R1 REAGENT LOT NUMBER WAS 242357 AND THE R3 REAGENT LOT NUMBER WAS 242359. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A MECHANICAL PROBLEM AND REPAIRED THE MODULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163891 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS P MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR