BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® GLU TEST STRIPS

    MDR report key: 23073465 · Received September 17, 2025

    Report

    Report Number
    1823260-2025-02987
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 26, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PZI
    PMA / PMN Number
    K220272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS® PULSE INSTRUMENT SERIAL NUMBER IS (B)(6). THE SERIAL NUMBER FOR THE COBAS® PULSE INSTRUMENT USED FOR THE REPEAT RESULT IS (B)(6). THE PRODUCT WAS REQUESTED FOR INVESTIGATION AND HAS NOT BEEN RECEIVED AT THIS TIME. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S TEST STRIPS WERE REQUESTED FOR INVESTIGATION BUT WERE NOT RECEIVED. THE PATIENT'S PERSONAL DEVICE IS CONTOUR NEXT. QC WAS WITHIN RANGE AT THE TIME OF THE EVENT. INVESTIGATION OF THE RETENTION MATERIAL WAS COMPLETED, AND NO ABNORMALITIES WERE FOUND IN THE RESULTS. THE TEST STRIPS ARE FACTORY-CALIBRATED AND RELEASED THROUGH A DEFINED PROCESS THAT ENSURES THE CLAIMED PERFORMANCE. ALL RELEVANT INSPECTIONS FOR THE AFFECTED LOT PASSED THE RELEASE REQUIREMENTS, CONFIRMING THE QUALITY OF THE LOT AT RELEASE. THERE WEREN'T ANY ERRORS LOGGED PRIOR TO OR AFTER THE MEASUREMENT WAS TAKEN. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. WITH THE INFORMATION PROVIDED, NO PRODUCT ISSUE WAS FOUND.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH GLUCOSE RESULT WITH THE COBAS® GLU TEST STRIPS FROM THE COBAS® PULSE INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULT AT 11:43 A.M. WAS 25.5 MMOL/L. FOLLOWING THE INITIAL MEASUREMENT, ANOTHER MEASUREMENT WAS TAKEN USING THE PATIENT'S DEVICE, WITH A RESULT OF 6.8 MMOL/L. AT 11:46 A.M., THE RESULT FROM ANOTHER COBAS PULSE INSTRUMENT WAS 10.5 MMOL/L. THE PATIENT WAS NOT TREATED BASED ON THE QUESTIONABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531133 COBAS® GLU TEST STRIPS PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI ROCHE DIAGNOSTICS 844228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown