BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 12524845 · Received September 24, 2021

    Report

    Report Number
    1823260-2021-02802
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 24, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAST CALIBRATION OCCURRED ON 15-AUG-2021 AND MULTIPLE CALIBRATIONS OCCURRED ON THIS DATE. TWO OF THE CALIBRATIONS RECOVERED HIGHER THAN EXPECTED AND THE LAST CALIBRATION PASSED. QUALITY CONTROLS WERE WITHIN RANGE, SHOWING NO INDICATION OF A REAGENT OR INSTRUMENT PERFORMANCE ISSUE. THE SAMPLE CENTRIFUGATION TIME MAY HAVE BEEN SHORTER AND THE CENTRIFUGATION SPEED MAY HAVE BEEN LONGER THAN RECOMMENDED BY THE TUBE MANUFACTURER. UPON REVIEW OF THE ALARM TRACE, MULTIPLE ABNORMAL SAMPLE ASPIRATION ALARMS, SAMPLE SHORT ALARMS, AND SYSTEM REAGENT SHORT ALARMS WERE OBSERVED. THE FIELD SERVICE ENGINEER FOUND LEAKING PROBES. VALVES WERE REPLACED. THE PATIENT SAMPLES WERE REPEATED ON THIS ANALYZER AND A SECOND ANALYZER AND RESULTS WERE WITHIN EXPECTED RANGES. THE CUSTOMER RAN CONTROLS AND RESULTS WERE WITHIN EXPECTED RANGES. NO FURTHER ISSUES HAVE OCCURRED AFTER THESE ACTIONS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS HCG + BETA TEST SYSTEM ON A COBAS 6000 E 601 MODULE. THE SAMPLE INITIALLY RESULTED IN A HCG+BETA VALUE OF 0.716 MIU/ML, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 140399 MIU/ML. THE REPEAT VALUE WAS BELIEVED TO BE CORRECT. THE PATIENT'S RESULT WAS CONFIRMED BY A QUALITATIVE TEST. THE HCG+BETA REAGENT LOT NUMBER WAS 51653905, WITH AN EXPIRATION DATE OF 30-APR-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423495 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR