BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20533024 · Received October 25, 2024

    Report

    Report Number
    1823260-2024-03077
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024 AND IT WAS ACCEPTABLE. THE QC RECOVERY WAS PROVIDED FOR 24-SEP-2024 AND IT WAS ACCEPTABLE. NO QC WAS PROVIDED FOR THE DAY OF THE EVENT. THE ALARM TRACE DID NOT SHOW ANY ABNORMALITY ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED MODULE DECONTAMINATION AND SOCKET REPLACEMENT DUE TO O-RINGS BREAKING DOWN. HE ALSO REPLACED THE OPTIC PATHWAY. THE FSE THEN PERFORMED CELL BLANK, PHOTOMETER READING, AND ADJUSTMENT. HE PERFORMED A HARDWARE CHECK AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTERWARD.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 771955. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CA2 RESULT WAS 6.5 MG/DL. THE CUSTOMER QUESTIONED THE LOW RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 9.0 MG/DL. THE SAMPLE WAS ALSO REPEATED ON ANOTHER C702 ANALYZER AND THE RESULT WAS 8.8 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819757 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown