BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® PULSE

    MDR report key: 20268577 · Received September 20, 2024

    Report

    Report Number
    1823260-2024-02728
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 24, 2024
    Report Date
    December 20, 2024
    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 GLU REAGENT LOT NUMBER WAS 748096. THE EXPIRATION DATE WAS NOT PROVIDED. QC WAS PERFORMED ON 23-AUG-2024 AND IT WAS ACCEPTABLE. THE TEST STRIPS ARE NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COBAS PULSE METER SERIAL NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION AND WAS TESTED USING A REFERENCE METHOD. FOUR DIFFERENT VENOUS BLOOD SAMPLES WERE MEASURED NATIVELY, ADJUSTED TO CONCENTRATIONS UP TO OVER 300 MG/DL, AND MEASURED WITH THE RETENTION SAMPLES LOT NUMBER 74809600 ON COBAS PULSE DEVICES. ANOTHER FOUR DIFFERENT VENOUS BLOOD SAMPLES WERE MEASURED NATIVELY AND ADJUSTED USING THE CUSTOMER'S DEVICE WHEN COMPARED TO 2 DEVICES. ALL VALUES WERE COMPARED WITH THE HEXOKINASE REFERENCE METHOD ON A COBAS 6000 ANALYZER. THE DEVIATIONS FROM THE REFERENCE METHOD FOR ALL BLOOD SAMPLES WERE APPROXIMATELY 1-6%. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS CONSISTENT WITH THE DILUTION EFFECT DUE TO THE SKIN DISINFECTANT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 78 PATIENTS' SAMPLES TESTED WITH COBAS GLU TEST STRIPS ON A COBAS PULSE INSTRUMENT (METER) WHEN COMPARED TO A DIFFERENT COBAS PULSE INSTRUMENT (METER). DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES WERE PROVIDED AS EXAMPLES. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 10 MG/DL. REPEAT RESULT: 369 MG/DL THE RESULTS WERE SIX MINUTES FROM EACH OTHER. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 256 MG/DL. REPEAT RESULT: 117 MG/DL (TESTED ON ANOTHER METER USING THE SAME TEST STRIPS). SAMPLE 3 (PATIENT 3): INITIAL RESULT: 222 MG/DL. REPEAT RESULT: 159 MG/DL (TESTED ON ANOTHER METER USING THE SAME TEST STRIPS). THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY WERE ABNORMALLY LOW AND THEY REPEATED THE TEST. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668215 COBAS® PULSE PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIEN PZI ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown