BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1371299 · Received February 10, 2009

    Report

    Report Number
    1823260-2009-01046
    Event Type
    Malfunction
    Date Received
    February 10, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 10, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IS HAVING ERRATIC PATIENT RESULTS FOR MULTIPLE CHEMISTRY ASSAYS. THE ASSAYS INCLUDE GLUCOSE, TOTAL PROTEIN, ALBUMIN, ALKALINE PHOSPHATSE AND AST. ERRONEOUS RESULTS WERE NOT RELEASED. CUSTOMER PROVIDED THE FOLLOWING FOURTEEN PATIENT EXAMPLES: PATIENT 1, INITIAL ALKALINE PHOSPHATSE 142 U/L, REPEAT 75/UL. PATIENT 2, INITIAL GLUCOSE 182 MG/DL, REPEAT 99 MG/DL; INITIAL ALBUMIN 6.5 G/DL, REPEAT 3.7 G/DL; INITIAL TOTAL PROTEIN 13.5 G/DL, REPEAT 6.4 G/DL; INITIAL ALKALINE PHOSPHATSE 167 U/L, REPEAT 88 U/L; INITIAL AST 48 U/L, REPEAT 27 U/L. PATIENT 3, INITIAL GLUCOSE 118 MG/DL, REPEAT 83 MG/DL; INITIAL TOTAL PROTEIN 13.3 G/DL, REPEAT 6.4 G/DL; INITIAL ALKALINE PHOSPHATASE 72 U/L, REPEAT 38 U/L; INITIAL ALBUMIN 2.9 G/DL, REPEAT 4.1 G/DL. PATIENT 4, INITIAL GLUCOSE 51 MG/DL, REPEAT 84 MG/DL, INITIAL TOTAL PROTEIN 11.5 G/DL, REPEAT 6.8 G/DL; INITIAL ALBUMIN 3.4 G/DL, REPEAT 4.2 G/DL; INITIAL ALKALINE PHOSPHATASE 150 U/L, REPEAT 86 U/L. PATIENT 5, INITIAL ALBUMIN 3.9 G/DL, REPEAT 4.6 G/DL; INITIAL ALKALINE PHOSPHATASE 166 U/L, REPEAT 93 U/L. PATIENT 6, INITIAL TOTAL PROTEIN 9.6 G/DL, REPEAT 7.1 G/DL; INITIAL AST 213 U/L, REPEAT 74 U/L. PATIENT 7, INITIAL TOTAL PROTEIN 10.4 G/DL, REPEAT 7.1 G/DL. PATIENT 8, INITIAL TOTAL PROTEIN 13.9 G/DL, REPEAT 7.1 G/DL; INITIAL ALKALINE PHOSPHATASE 141 U/L, REPEAT 76 U/L. PATIENT 9, INITIAL TOTAL PROTEIN 15.0 G/DL, REPEAT 7.6 G/DL; INITIAL ALBUMIN 6.0 G/DL, REPEAT 4.5 G/DL. PATIENT 10, INITIAL GLUCOSE 113 MG/DL, REPEAT 150 MG/DL. PATIENT 11, INITIAL TOTAL PROTEIN 11.6 G/DL, REPEAT 6.4 G/DL; INITIAL ALKALINE PHOSPHATASE 91 U/L, REPEAT 58 U/L. PATIENT 12, INITIAL ALBUMIN 5.6 G/DL, REPEAT 3.8 G/DL; INITIAL TOTAL PROTEIN 11.4 G/DL, REPEAT 6.4 G/DL; INITIAL ALKALINE PHOSPHATASE 130 U/L, REPEAT 82 U/L. PATIENT 13, INITIAL GLUCOSE 53 MG/DL, REPEAT 91 MG/DL; INITIAL ALKALINE PHOSPHATASE 231 U/L, REPEAT 126 U/L. PATIENT 14, INITIAL ALBUMIN 4.9 G/DL, REPEAT 3.4 G/DL. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE SYRINGE SEAL CAUSED LEAKING AIR INTO THE REAGENT VALVES. HE REPLACED THE REAGENT SEALS AND REPRIMED ALL REAGENT CHANNELS. CALIBRATIONS AND CONTROLS RESULTS WERE WITHIN SPECIFIED LIMITS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK