BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 16876027 · Received May 5, 2023

    Report

    Report Number
    1823260-2023-01516
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 26, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED THE MEASURING CELL AND PERFORMED ADJUSTMENTS. INSTRUMENT PERFORMANCE TESTING WAS RUN WITH ACCEPTABLE RESULTS. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS; ALL RESULTS WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION PERFORMED ON (B)(6) 2023 WAS OK AND THERE WERE NO ALARMS. THE PROVIDED QUALITY CONTROL DATA APPEARED ACCEPTABLE FOR THE FIRST CONTROL LEVEL. THE SECOND LEVEL CONTROL APPEARED ACCEPTABLE ON (B)(6) 2023. THE SAMPLE CENTRIFUGATION TIME MAY HAVE BEEN SHORTER AND THE SPEED MAY HAVE BEEN FASTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE WAS RESOLVED AFTER THE SERVICE ACTIONS HAD BEEN PERFORMED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS HCG STAT ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1, COLLECTED ON (B)(6) 2023: THE SAMPLE INITIALLY RESULTED IN AN HCG ST VALUE OF 103.8 MIU/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE WAS REPEATED WITH A NEW REAGENT PACK OF THE SAME REAGENT LOT, RESULTING IN AN HCG ST VALUE OF < 1.0 MIU/ML, ACCOMPANIED BY A DATA FLAG. A REFERENCE LABORATORY RESULT WAS NEGATIVE. NO INFORMATION ON THE METHOD USED WAS PROVIDED. PATIENT SAMPLE 2, COLLECTED ON (B)(6) 2023: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN AN HCG ST VALUE OF 10688 MIU/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE WAS REPEATED WITH A NEW REAGENT PACK OF THE SAME REAGENT LOT, RESULTING IN AN HCG ST VALUE OF 103326 MIU/ML, ACCOMPANIED BY A DATA FLAG. A REFERENCE LABORATORY RESULT WAS 105.993. NO INFORMATION ON THE METHOD USED AND UNITS OF MEASURE WERE PROVIDED. THE REPEAT RESULTS WERE DEEMED CORRECT. THE HCG STAT REAGENT LOT WAS 62829301 WITH AN EXPIRATION DATE OF 31-OCT-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195774 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown