BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1041305 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03900
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Description of Event or Problem · 1

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 1: INITIAL 3.8; REPEAT 0.81 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 10

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 10

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 10: INITIAL 3.6; REPEAT 0.86 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 11

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 11

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 11: INITIAL 4.0; REPEAT 0.56 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 12

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 12

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 12: INITIAL 4.0; REPEAT 0.5MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 2: INITIAL 4.2; REPEAT 0.30 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 3

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 3: INITIAL 4.1; REPEAT 0.44 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 4

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 4: INITIAL 4.0; REPEAT 0.57 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 5

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 5

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 5: INITIAL 3.9; REPEAT 0.69 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 6

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 6

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 6: INITIAL 3.5; REPEAT 1.00 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 7

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 7

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 7: INITIAL 3.5; REPEAT 0.64 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 8

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 8

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 8: INITIAL 4.3; REPEAT .24 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    Additional Manufacturer Narrative · 9

    THE FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE DUE TO TOTAL BILIRUBIN REAGENT EMPTY. CUSTOMER REPLACED REAGENT AND PERFORMED REAGENT PROBE VERTICAL ADJUSTMENT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 9

    TWELVE PT SAMPLES WITH DISCREPANT TOTAL BILIRUBIN RESULTS. PT 9: INITIAL 3.4; REPEAT 1.06 MG/DL. NO INFO PROVIDED TO DETERMINE WHICH PT SAMPLES WERE ERRONEOUSLY REPORTED. PTS NOT ADVERSELY AFFECTED.

    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 69 YR
    10 69 YR
    11 81 YR
    12 UNK
    2 65 YR
    3 79 YR
    4 61 YR
    5 54 YR
    6 51 YR
    7 85 YR
    8 61 YR
    9 46 YR