BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR PRE ANALYTICS

    MDR report key: 2883064 · Received December 21, 2012

    Report

    Report Number
    1823260-2012-06483
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    May 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) POTASSIUM RESULT FOR A SAMPLE THAT WAS PROCESSED ON THEIR MODULAR PRE ANALYTICS DEVICE (MPA). THE CUSTOMER STATED THEY RECEIVED AN "IPB ALARM" WHICH CAUSED THE DEVICE TO STOP. THE CUSTOMER RE-SET THE DEVICE AND RESTARTED IT. TEN SAMPLES WERE ALIQUOTED BY THE ALIQUOTER MODULE AND SENT TO THE MODULAR CORE ANALYZER. ON INSPECTION, THE SAMPLES APPEARED TO HAVE NOT BEEN SUFFICIENTLY CENTRIFUGED. OF THE TEN SAMPLES, FIVE WERE NOT PROCESSED ON THE MODULAR CORE SYSTEM. THE CUSTOMER WAS ONLY ABLE TO PROVIDE RESULTS FOR ONE PATIENT WITH A DISCREPANT RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED ALL THE OTHER SAMPLES REPEATED THE SAME AS THE FIRST RUN. THE PATIENT'S INITIAL POTASSIUM RESULT WAS 5.5 MMOL/L. THE REPEAT RESULT FROM THE SAME MODULAR CORE ANALYZER WAS 4.6 MMOL/L. THE REPEAT RESULT WAS CONSIDERED CORRECT. THE PATIENT WAS TREATED WITH KAYEXOLATE BASED ON THE INITIAL RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE TREATMENT. THE PATIENT'S NURSE STATED THE PATIENT HAS SINCE BEEN DISCHARGED. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE CHECKED THE OPERATION OF THE MPA. HE MONITORED PATIENT SAMPLES AND ALL TESTS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR PRE ANALYTICS AUTOMATED PREANALYTICAL SYSTEM LXG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1