BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 23270863 · Received October 10, 2025

    Report

    Report Number
    1823260-2025-04163
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCG+B REAGENT LOT NUMBER WAS 83810501 WITH AN EXPIRATION DATE OF 31-MAR-2026. THE CALIBRATION WAS LAST PERFORMED ON 11-SEP-2025. IT INITIALLY FAILED, BUT IT WAS SUCCESSFUL WHEN REPEATED. THE PROVIDED QC RECOVERY WAS WITHIN THE PROVIDED RANGES ON THE DAY OF THE EVENT. THE ALARM TRACE SHOWED ABNORMAL SAMPLE ASPIRATION AND ABNORMAL PROBE SUCKING ALARMS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER FOUND THAT THE CAUSE WAS DUE TO A BENT BEAD MIXER PADDLE. HE REPLACED THE PADDLE AND THE PINCH TUBING. HE THEN PERFORMED PRECISION STUDIES, AND THEY WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED CALIBRATION AND QC WITH SUCCESSFUL RESULTS. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG+B ASSAY ON A COBAS 6000 E601 MODULE. SAMPLE 1: INITIAL RESULT: 0.427 MIU/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE POINT OF CARE (POC) TEST RESULT AND THE PATIENT'S HISTORY. A NEW SAMPLE (SAMPLE 2) WAS THEN DRAWN FROM THE PATIENT AND TESTED: INITIAL RESULT: 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. REPEAT RESULT: 111622 MIU/ML (REPEATED BY AN AUTODILUTION). SAMPLE 1 AND SAMPLE 2 WERE REPEATED ON (B)(6) 2025, AND THE REPEAT RESULTS FOR BOTH SAMPLES WERE 10000 MIU/ML (ACCOMPANIED BY A DATA FLAG) AND 119327 MIU/ML (REPEATED BY AN AUTODILUTION). THE CUSTOMER DEEMED THE VALUE FROM SAMPLE 2 TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280733 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female