BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1001793 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01674
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT PLASMA SAMPLE WITH DISCREPANT CREATININE RESULTS. INITIAL RESULTS GAVE 6.03 MG/DL. SECOND SAMPLE OBTAINED NEXT DAY GAVE 0.6 MG/DL. INITIAL SAMPLE REPEATED GAVE 1.75 MG/DL. INITIAL SAMPLE REPEATED AN ADDITIONAL 10 TIMES RECOVERING EITHER 1.75 OR 1.74 MG/DL. A SERUM SAMPLE FROM THE SAME PATIENT DRAWN IN 2008 WAS ALSO TESTED AND GAVE CREATININE RESULT OF 0.95 MG/DL. ERRONEOUS RESULT WAS REPORTED. PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MOM - PRN CONSTIPATION| FLEET ENEMA - PRN CONSTIPATION| PERCOCET - EVERY FOUR HOURS| TRANSDERM NITRO PATCH - TWICE DAILY| ARTIFICIAL TEARS - PRN| SACLOFEN - FOUR TIMES DAILY| LOVENOX - DAILY| PLAVIX - DAILY| KLONOPIN - 3 TIMES DAILY| CELEXA - DAILY| ASPIRIN - DAILY| ACETAMINOPHEN - PRN| POTASSIUM - DAILY| PROLOSEC - TWICE DAILY| NYSTATIN - FOUR TIMES DAILY| ENABLEX - DAILY| LOPRESSOR - FOUR TIMES DAILY| LACTULOSE - DAILY| FEOSOL - DAILY| BIXUCODYL SUPP - PRN CONSTIPATION| LASIX - DAILY| ALBUTEROL - 3 TIMES DAILY