BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1599563 · Received February 16, 2010

    Report

    Report Number
    1823260-2010-01032
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER HAD THREE PATIENTS WITH QUESTIONABLE RESULTS WHICH WERE REPEATED ON A DIFFERENT MODULAR ANALYZER. NONE OF THE INITIAL RESULTS WERE REPORTED, THERE WAS NO AFFECT TO PATIENTS. PATIENT 1, INITIAL GLUCOSE RESULT 175, REPEAT 517 MG/DL (ACCOMPANIED BY A H DATA FLAG); INITIAL TOTAL PROTEIN RESULT 3.5, REPEAT 5.8 G/DL (ACCOMPANIED BY A L DATA FLAG); INITIAL ALBUMIN 5.5, REPEAT 3.0 G/DL (ACCOMPANIED BY L DATA FLAG); INITIAL ALKALINE PHOSPHATASE INITIAL RESULT 66, REPEAT 260 U/L. SAMPLE WAS PST, LITHIUM HEPARIN 16X100 TUBE. PATIENT 2, FEMALE, (B) (6), INITIAL GLUCOSE RESULT 74, REPEAT 182 MG/DL (ACCOMPANIED BY H DATA FLAG); INITIAL TOTAL PROTEIN 4.2, REPEAT 6.7 G/DL; INITIAL ALBUMIN RESULT 7.0, REPEAT 3.9 G/DL; INITIAL ALKALINE PHOSPHATASE 29 (ACCOMPANIED BY L DATA FLAG), REPEAT 96 U/L. SAMPLE WAS PST, LITHIUM HEPARIN 13X100 TUBE. PATIENT 3, FEMALE, (B) (6), INITIAL GLUCOSE RESULT 91, REPEAT 167 MG/DL (ACCOMPANIED BY H DATA FLAG). SAMPLE WAS PST, LITHIUM HEPARIN, 13X100 TUBE. REAGENT LOT NUMBERS USED: GLUCOSE 148274, TOTAL PROTEIN 148240, ALBUMIN 616143, ALKALINE PHOSPHATASE 618129. THE FIELD SERVICE REPRESENTATIVE FOUND A VACUUM LEAK WAS THE CAUSE AND REPLACED THE VACUUM TUBE. TO VERIFY ANALYZER OPERATION, HE RAN QC WHICH WAS ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR