BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 21955848 · Received May 4, 2025

    Report

    Report Number
    1219029-2025-00005
    Event Type
    Malfunction
    Date Received
    May 4, 2025
    Date of Event
    January 21, 2025
    Report Date
    May 2, 2025
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    PZI
    UDI-DI
    10385480636855
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SW DEVELOPMENT TEAM LOOKED AT THE 3 METERS THAT WERE RECEIVED FROM THE FIELD AND FOUND THE RECORDS THAT WERE MISSING THE PATIENT IDS IN THE METER'S DATABASE. THE CAUSE WAS NOT APPARENT. MOST RECORDS IN THE DATABASE WERE WITH PATIENT ID ALONG WITH SOME MISSING ONES. USING THE SAME METER CONFIGURATION RECEIVED FROM THE SITE, IN-HOUSE TESTING WAS PERFORMED. AFTER GOING OVER 200+ RESULTS ON 3 DIFFERENT METERS THE REPORTED PROBLEM WAS NOT SEEN/REPRODUCED. ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. INCIDENTALLY, FIRMWARE 0.0.13.50 WAS INSTALLED AT THE CUSTOMER SITE. THERE HAVE BEEN NO FURTHER INCIDENTS OF MISSING PATIENT ID'S FROM THE METER DATABASE. A DHR REVIEW WAS PERFORMED. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

    Description of Event or Problem · 0

    METER RAN PROPERLY DURING PATIENT TEST, BUT WHEN METER CONNECTED TO NN AND ONTO QML (MIDDLEWARE) THE PATIENT ID NUMBER WAS DROPPED FROM THE METER SOME HOW. THIS CAUSES AN EXCEPTION IN MIDDLEWARE FORCING THE POC TO MODIFY AND ADJUST THE PATIENT ID PROPERLY BEFORE GOING TO PATIENTS CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820198 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORPORATION 63685 10385480636855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown