BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 21930680 · Received April 29, 2025

    Report

    Report Number
    1219029-2025-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    January 12, 2025
    Report Date
    April 29, 2025
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURNED PRODUCT A DETAILED INVESTIGATION ON THE FAILED PRODUCT COULD NOT BE PERFORMED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. FURTHER INFORMATION PROVIDED INDICATES THE METER RAN PROPERLY DURING PATIENT TEST, BUT WHEN METER CONNECTED TO NOVA NET AND ON TO QML (MIDDLEWARE) THE PATIENT ID WAS NO LONGER VISIBLE. THIS CAUSES AN EXCEPTION IN MIDDLEWARE FORCING THE POC TO MODIFY AND ADJUST THE PATIENT ID PROPERLY BEFORE GOING ONTO THE PATIENT'S CHART. THE CUSTOMER FURTHER INDICATED THAT THIS WAS A RANDOM OCCURRENCE, IT ONLY HAPPENED ONCE ON THIS METER. THE METER REMAINED IN SERVICE AT THE FACILITY. THE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. WHEN NOVA BIOMEDICAL REQUESTED FURTHER INFORMATION ON POTENTIAL PATIENT IMPACT THE ANSWER PROVIDED WAS "UNKNOWN". A DHR REVIEW WAS PERFORMED. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

    Description of Event or Problem · 0

    "PATIENT ID SHOWS UP AS UNKNOWN IN QML AND ON THE METER THERE IS A BLANK SPACE FOR THAT TEST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428280 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORPORATION 63685 0324119249 00385480636858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown