BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1670681 · Received April 30, 2010

    Report

    Report Number
    1823260-2010-02582
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD APPLICATION SPECIALIST DETERMINED THE USER ACCIDENTALLY DELETED ALL CALIBRATORS ON THE SYSTEM AND RELOADED/ADDED THE CALIBRATORS BACK ON. THE TOTAL BILIRUBIN ASSAY REQUIRED A PACK CALIBRATION AND A LOT CALIBRATION AFTER THE CHANGES. SAMPLES WERE RUN BEFORE CALIBRATIONS WERE DONE. THE USER PERFORMED THE NECESSARY CALIBRATIONS WHICH WERE ACCEPTABLE. QC RECOVERED WITHIN ACCOUNT'S ACCEPTABLE RANGES.

    Description of Event or Problem · 1

    THE USER STATED TOTAL BILIRUBIN RESULTS WERE ERRONEOUSLY HIGH AND WERE REPORTED. SHE STATED SHE HAD ACCIDENTALLY DELETED ALL OF HER CALIBRATORS ON THE SYSTEM AND THEN REINSTALLED THEM BY DOWNLOADING THEM. WHEN THEY RAN PATIENT SAMPLES, THEY HAD 36 BILIRUBIN RESULTS THAT HAD TO BE CORRECTED BECAUSE "IT SEEMED LIKE THE DECIMAL PLACE WAS OFF ON THE SYSTEM". THE USER RECALIBRATED THE ASSAY, RAN QC AND RESULTS WERE ACCEPTABLE. NO PATIENTS WERE AFFECTED AS THE RESULTS WERE CORRECTED DURING THE NEXT SHIFT. THE BILIRUBIN REAGENT LOT NUMBER WAS 15830300. SAMPLES ARE LISTED AS INITIAL RESULT FOLLOWED BY REPEAT RESULT FOR ANOTHER C501 ANALYZER. ALL RESULTS ARE IN MG/DL. THE FOLLOWING SAMPLE WERE REPEATED ON (B)(6) 2010. SAMPLE 1: ((B)(6) FEMALE) 5.9, 0.6. SAMPLE 2: ((B)(6) MALE) 29.7, 2.8. SAMPLE 3: ((B)(6), FEMALE) 3.2, 0.2. SAMPLE 4: ((B)(6), MALE) 5.0, 0.4. SAMPLE 5: ((B)(6), FEMALE) 2.5, 0.2. SAMPLE 6: ((B)(6), FEMALE) 2.8, 0.3. SAMPLE 7: ((B)(6), FEMALE) 5.5, 0.5. SAMPLE 8: ((B)(6), FEMALE) 11.7, 1.1. SAMPLE 9: ((B)(6), FEMALE) 1.4, 0.1. SAMPLE 10: ((B)(6), MALE) 2.9, 0.3. SAMPLE 11: ((B)(6), MALE) 5.0, 0.4. SAMPLE 12: ((B)(6), FEMALE) 1.6, 0.1. THE FOLLOWING SAMPLE WERE REPEATED ON (B)(6) 2010. SAMPLE 13: ((B)(6), FEMALE) 2.8, 0.2. SAMPLE 14: ((B)(6), FEMALE) 3.5, 0.3. SAMPLE 15: ((B)(6), FEMALE) 4.6, 0.4. SAMPLE 16: ((B)(6), FEMALE) 4.5, 0.4. SAMPLE 17: ((B)(6), FEMALE) 4.2, 0.3. SAMPLE 18: ((B)(6), FEMALE) 4.5, 0.4. SAMPLE 19: ((B)(6), MALE) 4.8, 0.4. SAMPLE 20: ((B)(6), FEMALE) 4.4, 0.4. SAMPLE 21: ((B)(6), FEMALE) 2.1, 0.1. SAMPLE 22: ((B)(6), MALE) 5.2, 0.5. SAMPLE 23: ((B)(6), FEMALE) 3.3, 0.3. SAMPLE 24: ((B)(6), FEMALE) 3.6, 0.3. SAMPLE 25: ((B)(6), FEMALE) 3.9, 0.3. SAMPLE 26: ((B)(6), MALE) 2.7, 0.2. SAMPLE 27: ((B)(6), MALE) 3.5, 0.3. SAMPLE 28: ((B)(6), MALE) 4.6, 0.4. SAMPLE 29: ((B)(6), MALE) 4.0, 0.3. SAMPLE 30: ((B)(6), MALE) 6.4, 0.5. SAMPLE 31: ((B)(6), MALE) 4.8, 0.3. SAMPLE 32: ((B)(6), FEMALE) 5.2, 0.4. SAMPLE 33: ((B)(6), FEMALE) 5.9, 0.5. SAMPLE 34: ((B)(6), MALE) 6.4, 0.5. SAMPLE 35: ((B)(6), MALE) 4.6, 0.4. SAMPLE 36: ((B)(6), MALE) 11.6, 1.1.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE FIRST SULU WAS FIRED ACROSS STOMACH TO CREATE A GASTRIC POUCH. SOME OF THE STAPLES DID NOT FORM PROPERLY. THE 2ND SULU WAS FIRED BEHIND THE FIRST SULU AND THE SAME CONDITION OCCURRED WITH SOME OF THE STAPLES NOT PROPERLY FORMED. A 3RD SULU WAS FIRED SUCCESSFULLY BEHIND 2ND STAPLE LINE. GREEN RELOADS WERE USED SUCCESSFULLY FOR THE REMAINDER OF GASTRIC POUCH FORMATION. THE FIRST AND SECOND STAPLE LINES WERE EXCISED AND TISSUE WAS KEPT BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JFM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR