BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 2494523 · Received March 16, 2012

    Report

    Report Number
    1823260-2012-01484
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 16, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE ARM 2 WAS MISADJUSTED AND THERE WAS A MECHANICAL FAILURE WITH THE STIRRER MECHANISM.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW CREATININE PLUS (CREATININE) RESULTS FOR FOUR PATIENT SAMPLES. OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, ONLY THE RESULTS FOR ONE PATIENT WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. ALL OF THE SAMPLES WERE PROCESSED BY THE MODULAR PREANALYTIC (MPA) SYSTEM WHICH ALIQUOTED THE SAMPLES INTO A CUP WHICH WAS USED FOR THE INITIAL TESTING. THE ORIGINAL RESULT WAS 0.10 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT FAILED A DELTA CHECK IN THE USER'S HOST SYSTEM SO THE USER PULLED THE ORIGINAL PRIMARY TUBE AND RETESTED IT ON DIFFERENT ANALYTICAL D MODULE ANALYZER. THE RESULT WAS 1.25 MG/DL WHICH WAS DEEMED CORRECT AND WAS ISSUED AS A CORRECTED REPORT. NO ADVERSE EVENTS OCCURRED AND NO PATIENTS WERE TREATED OR HAD TREATMENT WITHHELD BASED UPON ERRONEOUS RESULTS. THE LOT NUMBER AND EXPIRATION DATE OF THE REAGENT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE ARM 2 WAS MISADJUSTED AND THERE WAS A MECHANICAL FAILURE WITH THE STIRRER MECHANISM. HE ADJUSTED SAMPLE ARM 2 AND CLEANED AND LUBRICATED THE STIRRER SPINDLES AND GEARS. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED ALL PROBE ADJUSTMENTS, ADJUSTED THE LEVEL OF THE RINSE AND DETERGENT, CHECKED THE STIRRERS AND REAGENT NOZZLE RINSE, PERFORMED COMMON LINE CLEANING, 50 MECHANISM CHECKS AND OBSERVED PROPER OPERATION WITHOUT ERROR. THE USER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH PASSED ACCORDING TO THE SITE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1