BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 20260712 · Received September 19, 2024

    Report

    Report Number
    1823260-2024-02710
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 27, 2024
    Report Date
    November 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    08430215011546
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE REPRESENTATIVE FOUND THE RINSE TUBING WAS CRACKED. THE RINSE TUBING WAS ADJUSTED TO RESOLVE THE LEAK. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. PATIENT 1: (ID: (B)(6): THE INITIAL RESULT WAS 177 MMOL/L. THE REPEATED RESULT WAS 135 MMOL/L. PATIENT 2: (ID: (B)(6): THE INITIAL RESULT WAS 167 MMOL/L. THE REPEATED RESULT WAS 138 MMOL/L. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE FILED. THE SAMPLES WERE REPEATED DUE TO FAILING DELTA CHECKS AND THE INITIAL RESULT FOR PATIENT 1 DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER ANALYZER AND WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431306 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS ASKU 08430215011546

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male PATIENT 1: ALBUTEROL| PATIENT 1: ASPIRIN| PATIENT 1: BRISDOL| PATIENT 1: CARVETILOL| PATIENT 1: DEXTROSE AND GLUCOSE| PATIENT 1: FLOMAX| PATIENT 1: HYDROCORTISONE| PATIENT 1: KETOROLAC| PATIENT 1: LEVANOX| PATIENT 1: LEVOTHYROXINE| PATIENT 1: LORAZEPAM| PATIENT 1: MAGNESIUM SULFATE| PATIENT 1: MENTHOL ZINC OXIDE TOPICAL OINTMENT| PATIENT 1: NORFLEX INJECTABLE| PATIENT 1: PEPSID| PATIENT 1: PLAVIX| PATIENT 1: POTASSIUM CHLORIDE| PATIENT 1: POTASSIUM PHOSPHATE/SODIUM PHOSPHATE| PATIENT 1: SODIUM CHLORIDE| PATIENT 1: SUROSEMIDE| PATIENT 2: BENADRYL INJECTION| PATIENT 2: LABETALOL| PATIENT 2: NORMAL SALINE 1000ML INFUSION| PATIENT 2: PROCHLORTERAZINE INJECTION