BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1951324 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00083
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE JAFFE (CREATININE) RESULTS FOR FOUR PATIENT SAMPLES. THE USER ONLY PROVIDED DATA FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.20 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN THEN CALLED AND QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME P MODULE WITH A RESULT OF 0.5 MG/DL AND ON P MODULE ANALYZER SERIAL NUMBER (B)(4) WITH A RESULT OF 0.51 MG/DL. THE USER STATED SHE BELIEVED THE PATIENT WAS MOVED TO THE ICU AFTER THE INCIDENT AND THAT THE PHYSICIAN WAS TREATING THE PATIENT BASED ON THE ERRONEOUS RESULT, BUT COULD NOT PROVIDE FURTHER INFORMATION. NO ADVERSE EVENTS WERE ALLEGED. THE CREATININE REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS OUT OF ALIGNMENT. HE CLEANED AND DECONTAMINATED THE SAMPLE LINES AND PROBE AND PREFORMED AN ALIGNMENT FOR THE SAMPLE PROBE. HE VERIFIED THE ANALYZER OPERATION BY RUNNING PRECISION TESTING AND QUALITY CONTROL WHICH PASSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1