BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® GLU TEST STRIPS

    MDR report key: 23769587 · Received December 10, 2025

    Report

    Report Number
    1823260-2025-05043
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PZI
    PMA / PMN Number
    K220272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS® PULSE SERIAL NUMBERS ARE (B)(6). THE PRODUCT WAS REQUESTED FOR INVESTIGATION. ALL OF THE STRIPS WERE CONSUMED AND WILL NOT BE RETURNED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULT USING THE COBAS® GLU TEST STRIPS WITH TWO COBAS® PULSE DEVICES FOR ONE PATIENT. THE INITIAL RESULT AT 12:21 WAS 238 MG/DL, WITH SERIAL NUMBER (B)(6). ANOTHER RESULT AT 12:21 WAS 173 MG/DL, WITH SERIAL NUMBER (B)(6). A VENOUS SAMPLE WAS COLLECTED AND TESTED USING THE COBAS PRO AT 15:15, WITH A RESULT OF 165 MG/DL. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE QUESTIONABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989878 COBAS® GLU TEST STRIPS PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI ROCHE DIAGNOSTICS 861467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female