BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1493880 · Received August 17, 2009

    Report

    Report Number
    1823260-2009-05490
    Event Type
    Malfunction
    Date Received
    August 17, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 17, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE CONFIRMED THE SAMPLE PROBE PIERCED THE CAPPED SAMPLE TUBE DURING OPERATION. HE ALSO NOTED THE USER WAS RUNNING A 5 ML SAMPLE TUBE IN A RACK DEFINED FOR 7 ML SAMPLE TUBES. HE REVIEWED THE PROPER SETTINGS AND STATED THE USER WILL UPDATE THE SETTINGS. TO VERIFY THE ANALYZER PERFORMANCE, THE USER RAN CALIBRATION AND QC.

    Description of Event or Problem · 1

    THE USER STATED ON THE FIRST DAY USING THE INTEGRA 400, SHE LOADED PATIENT SAMPLES AND NOTED THE CALCIUM AND SODIUM RESULTS WERE HIGH FOR ALL SAMPLES. THE TOTAL NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT PROVIDED, BUT ALL SAMPLES WERE IN 5 ML GOLD TOP BECTON DICKENSON VACUTAINER SST BRAND TUBES. THE USER DISCOVERED SHE HAD FORGOTTEN TO REMOVE THE VACUTAINER STOPPERS FROM THE SAMPLE TUBES AND THE PROBE WAS PIERCING THE CAP. THE USER STATED SHE DID NOT RECEIVE ANY HARDWARE ALARMS AND STATED THE PROBE LOOKED FINE AND WAS NOT BENT OR BROKEN. THE USER PROVIDED DATA FOR 11 PATIENT SAMPLES. THE SODIUM RESULTS IN MMOL PER L ARE INITIAL RESULT, REPEAT RESULT, RESULT AFTER RECALIBRATION AND THE RESULT AFTER REMOVING THE SAMPLE TUBE CAP. THE CALCIUM RESULTS IN MG PER DL ARE INITIAL RESULT, REPEAT RESULT, RESULT AFTER CHANGING THE REAGENT PACK AND RECALIBRATION AND THE RESULT AFTER REMOVING THE SAMPLE TUBE CAP. SAMPLE 1 SODIUM RESULTS ARE 151, 152, 154 AND 133. CALCIUM RESULTS ARE 12.2, 12.6, 11.2 AND 8.0. SAMPLE 2 SODIUM RESULTS ARE 152, 152, 153 AND 133. CALCIUM RESULTS ARE 14.1, 13.9, 14.0 AND 8.7. SAMPLE 3 SODIUM RESULTS ARE 151, 152, 153 AND 133. CALCIUM RESULTS ARE 12.1, 12.5, 12.1 AND 7.5. SAMPLE 4 SODIUM RESULTS ARE 153, 153, 154 AND 134. CALCIUM RESULTS ARE 15.2, 14.8, 13.9 AND 9.3. SAMPLE 5 CALCIUM RESULTS ARE 12.6, 13.8, 14.0 AND 8.5. SAMPLE 6 CALCIUM RESULTS ARE 14.6, 14.2, 14,2 AND 8.8. SAMPLE 7 CALCIUM RESULTS ARE 14.1, 14.1, 13.6 AND 8.7. SAMPLE 8 SODIUM RESULTS ARE 152, 152, 153 AND 133. CALCIUM RESULTS ARE 12.1, 12.0 AND 7.3. SAMPLE 9 SODIUM RESULTS ARE 152, 152, 153 AND 133. CALCIUM RESULTS ARE 15.1, 14.1, 14.5 AND 9.2. SAMPLE 10 SODIUM RESULTS ARE 138, 138 AND 122. CALCIUM RESULTS ARE 13.2, 12.9, 12.9 AND 8.0. SAMPLE 11 SODIUM RESULTS ARE 150, 150 AND 130. CALCIUM RESULTS ARE 13.6, 13.7, 11.4 AND 8.3. NONE OF THE RESULTS WERE RELEASED OR REPORTED AND NO PATIENTS WERE AFFECTED OR TREATED BASED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK