BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTERGRA 800

    MDR report key: 1002626 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01365
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    November 18, 2003
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT DISCREPANT RESULTS FOR MULTIPLE PTS FROM 2003 TO 2007. THE FOLLOWING DATA WAS PROVIDED; UNITS OF MEASURE WERE NOT PROVIDED. TESTS INVOLVED ARE SODIUM (NA), POTASSIUM (K), BICARBONATE (CO2), CREATININE (CREAT), BUN, ALBUMIN (ALB) AND TOTAL PROTEIN (TP). EACH SAMPLE WAS REPEATED EITHER TWO, THREE OR FOUR TIMES. AND = &; #175: CREAT = 99; REPEATS = 176, 177 & 178; #176: K = 3.6; REPEATS = 4.2, 4.2 & 4.2; #177: CREAT = 165; REPEATS = 256, 254 & 262; #178: NA = 134; REPEATS = 124, 122 & 122; # 179: NA = 136; REPEATS = 110, 109 & 110. K = 3.2; REPEATS = 2.5, 2.5 & 2.5; #180: K = 3.8; REPEATS = 4.5, 4.5 & 4.5; #181: K = 3.4; REPEATS = 4.5, 4.5 & 4.5; #182: CREAT = 413; REPEATS = 719, 709 & 721; #183: NA = 110; REPEATS = 117, 118 & 117; #184: NA = 133; REPEATS = 155, 153 & 155. K = 5; REPEATS = 4.1, 4 & 4.1; #185; CREAT = 206; REPEATS = 368, 374 & 376. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTERGRA 800 CLINICAL CHEMISTRY ANALYZER- JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK