BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® GLU TEST STRIPS

    MDR report key: 22609392 · Received July 25, 2025

    Report

    Report Number
    1823260-2025-02293
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 7, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PZI
    PMA / PMN Number
    K220272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE COBAS PULSE GLUCOSE TEST STRIP LOT NUMBER WAS 788443. THE TEST STRIP EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION, BUT THERE WERE NO ADDITIONAL TEST STRIPS REMAINING IN THE VIAL THE CUSTOMER WAS USING. THE INVESTIGATION IS ONGOING. MEDWATCH FIELD E1 INITIAL REPORTER ESTABLISHMENT NAME - THE FULL FACILITY NAME WAS PROVIDED AS (B)(6).

    Additional Manufacturer Narrative · 0

    THE DEVICE RAW DATA AND MEASUREMENT TIMES WERE NOT AVAILABLE, SO NO FURTHER INVESTIGATIONS COULD BE PERFORMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT GLUCOSE RESULT FOR ONE PATIENT TESTED WITH A COBAS® PULSE INSTRUMENT. AT 06:51, A SAMPLE FROM THE PATIENT WAS TESTED USING THE INSTRUMENT, RESULTING IN A GLUCOSE VALUE OF < 10 MG/DL. AT 06:53, A SAMPLE FROM THE PATIENT WAS TESTED USING A SECOND COBAS PULSE INSTRUMENT, RESULTING IN A GLUCOSE VALUE OF 227 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267331 COBAS® GLU TEST STRIPS PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI ROCHE DIAGNOSTICS 788443

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female BOKEY| LIPID-LOWERING DRUGS| ORAL MORPHINE-BASED PAINKILLERS| SELF-PREPARED INSULIN