BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2011474 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01256
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS AND PROVIDED DATA FOR EIGHT DIFFERENT PATIENT SAMPLES. OF THE DATA PROVIDED, THE FOLLOWING RESULTS WERE DISCREPANT. THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2011 AFTER THE FIELD SERVICE REPRESENTATIVE SERVICE VISIT WAS COMPLETED. PATIENT SAMPLE 1 INITIAL ION SELECTIVE ELECTRODE (ISE) POTASSIUM RESULT WAS 4.1 MMOL/L AND THE REPEAT RESULT WAS 5.2 MMOL/L. THE INITIAL HDL- CHOLESTEROL PLUS GENERATION 3 (HDL) RESULT WAS 99 MG/DL AND THE REPEAT RESULT WAS 60 MG/DL. PATIENT SAMPLE 2 INITIAL CHOLESTEROL RESULT WAS 63 MG/DL AND THE REPEAT RESULT WAS 188 MG/DL. PATIENT SAMPLE 3 INITIAL CREATININE JAFFE RESULT WAS 1.1 MG/DL AND THE REPEAT RESULT WAS 0.6 MG/DL. PATIENT SAMPLE 4 INITIAL HDL RESULT WAS 105 MG/DL AND THE REPEAT RESULT WAS 49 MG/DL. THE INITIAL ALANINE AMINOTRANSFERASE (ALT) RESULT WAS 19 U/L AND THE REPEAT RESULT WAS 29 U/L. PATIENT SAMPLE 5 INITIAL CREATININE JAFFE RESULT WAS 1.8 MG/DL AND THE REPEAT RESULT WAS 0.7 MG/DL. THE INITIAL CALCIUM RESULT WAS 6.7 MG/DL AND THE REPEAT RESULTS WAS 8.6 MG/DL. THE INITIAL ALT RESULT WAS 50 U/L AND THE REPEAT RESULT WAS 25 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED OR TESTED AS THE RESULTS THAT NEEDED TO BE CORRECTED WERE CALLED TO THE DOCTOR IN A TIMELY FASHION. THE ALT REAGENT LOT NUMBERS WERE 63068701 AND 63036301. THE CALCIUM REAGENT LOT NUMBERS WERE 63012001 AND 63360901. THE CHOLESTEROL REAGENT LOT NUMBER WAS 63122101. THE CREATININE REAGENT LOT NUMBERS WERE 63352501 AND 63145201. THE HDL REAGENT LOT NUMBERS WERE 62951801 AND 62708401. THE POTASSIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDICS FAILURE DUE TO THE TUBE COMING OFF THE VACUUM TRAP BOTTLE. HE PERFORMED CORRECTIVE MAINTENANCE AND REATTACHED AND SECURED THE TUBE TO THE BOTTLE. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING AND THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATIONS.

    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