BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1647054 · Received March 31, 2010

    Report

    Report Number
    1823260-2010-01928
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER NOTICED THE SAMPLE PROBE DRIPPING AND RECEIVED ERRONEOUS RESULTS FOR MULTIPLE PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 26 SAMPLES WERE DISCREPANT. ALL RESULTS LISTED ARE INITIAL RESULT FOLLOWED BY THE REPEAT RESULT ON ANOTHER P MODULE. BICARBONATE AND SODIUM RESULTS ARE IN MMOL/L. GLUCOSE, CALCIUM AND CREATININE RESULTS ARE IN MG/DL. TOTAL PROTEIN RESULTS ARE IN G/DL. AST, ALT AND ALP RESULTS ARE IN U/L. SAMPLE 1: BICARBONATE 0, 24; GLUCOSE 9, 128; CALCIUM 2.2, 9.2. SAMPLE 2: GLUCOSE 7, 90; CALCIUM 10.2, 9.2, TOTAL PROTEIN 0.3, 6.2; AST 6, 22, ALT 4, 13; ALP 24, 71. SAMPLE 3: SODIUM 142, 134, BICARBONATE 0, 25; GLUCOSE 7, 98; CALCIUM 2.8, 8.8; TOTAL PROTEIN 0.4, 6.7; AST 10, 23; ALT 55, 29; ALP 23, 51. SAMPLE 4: SODIUM 138, 130; BICARBONATE 0, 23; GLUCOSE 7, 90; CREATININE 0.1, 1.0; CALCIUM 9.3, 8.3, TOTAL PROTEIN 0.2, 6.1; AST 7, 19; ALP 25, 71. SAMPLE 5: BICARBONATE 0, 26; GLUCOSE 4, 90; CALCIUM 2.0, 9.2; TOTAL PROTEIN 0.3, 7.4; AST 1, 20; ALP 31, 87. SAMPLE 6: SODIUM 131, 125; BICARBONATE 0, 23; GLUCOSE 12, 93; TOTAL PROTEIN 0.2, 7.1; AST 6, 17; ALT 8, 27; ALP 26, 78. SAMPLE 7: BICARBONATE 0, 20; GLUCOSE 8, 182; CALCIUM 2.1, 8.7; TOTAL PROTEIN 0.2, 6.4; AST 5, 17; ALT 29, 15; ALP 38, 112. SAMPLE 8: GLUCOSE 3, 88; CALCIUM 7.9, 9.0, TOTAL PROTEIN 0.2, 6.5; AST 7, 19, ALP 30, 102. SAMPLE 9: GLUCOSE 505, 156; AST 7, 23. SAMPLE 10: GLUCOSE 9, 110; CALCIUM 2.1, 8.6; TOTAL PROTEIN 0.3, 6.5; AST 12, 40; ALP 23, 65. SAMPLE 11: GLUCOSE 14, 98; CALCIUM 14.8, 8.9; TOTAL PROTEIN 0.4, 6.4; AST 6, 15; ALT 6, 14; ALP 31, 71. SAMPLE 12: BICARBONATE 0, 26; GLUCOSE 4, 96; CALCIUM 2.1, 9.3; TOTAL PROTEIN 0.2, 6.9; AST 2, 21; ALP 20, 71. SAMPLE 13: SODIUM 137, 131, BICARBONATE 0, 23; GLUCOSE 10, 71; CREATININE 0.2, 1.4; CALCIUM 13.8, 8.3; TOTAL PROTEIN 0.3, 6.6; AST 14, 32; ALT 9, 27; ALP 32, 84. SAMPLE 14: BICARBONATE 1, 23; GLUCOSE 9, 163; CALCIUM 2.6, 8.9; TOTAL PROTEIN 0.4, 6.1; AST 7, 19; ALT 34, 18; ALP 14, 36. SAMPLE 15: TOTAL PROTEIN 0.3, 6.4; AST 5, 16; ALT 6, 13; ALP 19, 51. SAMPLE 16: SODIUM 140, 130; BICARBONATE 0, 26; GLUCOSE 3, 75; TOTAL PROTEIN 0.3, 6.5; AST 3, 16; ALT 5, 18; ALP 26, 68. SAMPLE 17: SODIUM 138, 132; BICARBONATE 0, 23; GLUCOSE 3, 133; CALCIUM 0.1, 8.9; TOTAL PROTEIN 0.2, 7.0; AST 1, 15; ALT 22, 19; ALP 1, 69. SAMPLE 18: GLUCOSE 6, 86; CALCIUM 0.2, 8.8; TOTAL PROTEIN 0.2, 6.1; AST 2, 15; ALP 21, 60. SAMPLE 19: SODIUM 140, 127; GLUCOSE 6, 101; CREATININE 0.1, 1.0; CALCIUM 7.1, 8.5; TOTAL PROTEIN 0.2, 5.8; AST 1, 17; ALP 18, 57. SAMPLE 20: SODIUM 139, 126; BICARBONATE 0, 23; GLUCOSE 10, 186; CALCIUM 7.0, 8.2; TOTAL PROTEIN 0.2, 6.5; AST -1, 18; ALP 1, 71. SAMPLE 21: SODIUM 138, 127; GLUCOSE 1, 115; CREATININE 0.2, 1.3; TOTAL PROTEIN 0.2, 6.6; AST 7, 23; ALP 18, 57. SAMPLE 22: SODIUM 138, 127; GLUCOSE 4, 79; CREATININE 0.3, 1.7; CALCIUM 2.2, 8.7; TOTAL PROTEIN 0.2, 6.1; AST 7, 22; ALP 17, 46. SAMPLE 23: BICARBONATE 1, 23; GLUCOSE 5, 99; CALCIUM 2.2, 9.1; AST 6, 21. SAMPLE 24: SODIUM 140, 132; BICARBONATE 0, 23; GLUCOSE 6, 86; CALCIUM 10.5, 8.7; TOTAL PROTEIN 0.3, 6.5; AST 3, 27; ALP 2, 47. SAMPLE 25: TOTAL PROTEIN 0.1, 6.6; AST 2, 22; ALP 8, 104. SAMPLE 26: SODIUM 140, 129; BICARBONATE 0, 21; GLUCOSE 4, 84; CALCIUM 9.6, 8.4; TOTAL PROTEIN 0.3, 6.3; AST 2, 22; ALP 7, 62. NONE OF THE INITIAL RESULTS WERE REPORTED AND NO PATIENTS WERE ADVERSELY AFFECTED. THE REAGENT LOT NUMBERS WERE ALP: 61945301, ALT: 61425801, AST: 61894401, CALCIUM: 61828301, BICARBONATE: 61564801, GLUCOSE: 61946701, TOTAL PROTEIN 61630201. THE CREATININE REAGENT LOT NUMBER AND SODIUM ELECTRODE LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SV1 VALVE WAS DEFECTIVE AND REPLACED IT. HE VERIFIED THE ANALYZER OPERATION BY PRIMING THE SYSTEM WITH NO LEAKING OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1