BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 3032542 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02001
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW CALCIUM RESULTS FOR 24 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON EITHER ANALYTICAL D MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, ONLY THE RESULTS FOR 2 PATIENT SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 8.5 MG/DL AND THE REPEAT RESULT WAS 10.6 MG/DL. PATIENT SAMPLE 2 INITIAL RESULT WAS 8.4 MG/DL AND THE REPEAT RESULT WAS 10.2 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE CALCIUM R1 REAGENT LOT NUMBER WAS 68289701 WITH AN EXPIRATION DATE OF 07/31/2014. THE CALCIUM R2 REAGENT LOT NUMBER WAS 68289601 WITH AN EXPIRATION DATE OF 07/31/2014. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE RINSE NOZZLES WERE STICKING. HE REMOVED AND CLEANED THE RINSE NOZZLES, VERIFIED THE NOZZLE SPRING OPERATION AND CHECKED THE INSTRUMENT. THE CUSTOMER RAN CALIBRATION AND QC WITH ALL RESULTS WITHIN CUSTOMER'S SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE RAN A 30 CUP PRECISION WHICH PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137115 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1