BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1221552 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08198
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 26, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 1, INITIAL CREATININE RESULT 2.09 MG/DL, REPEAT 0.77 MG/DL. THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 2, INITIAL CREATININE RESULT 1.51 MG/DL, REPEAT 0.68 MG/DL. THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 3

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 3, INITIAL CREATININE 1.51 MG/DL, REPEAT 0.81 MG/DL. THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 4

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 4, INITIAL CREATININE 1.92 MG/DL, REPEAT 1.20 MG/DL. THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 5

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 5, INITIAL CREATININE 2.33 MG/DL, REPEAT 0.91 MG/DL. THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 6

    USER EXPERIENCED DISCREPANT CREATININE OR DIRECT BILIRUBIN RESULTS FOR TEN PT SAMPLES. PT 6, INITIAL CREATINE 1.97 MG/DL, REPEAT 0.91 MG/DL. PT 7, INITIAL CREATININE 1.39 MG/DL, REPEAT 0.79 MG/DL. PT 8, INITIAL CREATININE 1.72 MG/DL, REPEAT 0.77 MG/DL. PT 9, INITIAL CREATININE 1.58 MG/DL, REPEAT 0.90 MG/DL. PT 10, INITIAL DIRECT BILIRUBIN 2.14, REPEAT -0.23 (NO UNITS PROVIDED). THE INITIAL RESULTS WERE REPORTED. ONCE THE LAB REALIZED THE RESULTS WERE INCORRECT, THE PHYSICIAN WERE IMMEDIATELY PHONED INSTRUCTING THEM NOT TO USE THE RESULTS. NO PT WERE ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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
    2 UNK
    3 UNK
    4 UNK
    5 UNK
    6 UNK