BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP

    MDR report key: 25299705 · Received May 27, 2026

    Report

    Report Number
    1219029-2026-00035
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOVA BIOMEDICAL RECEIVED ANONYMOUS MEDWATCH REPORT # MW5187509 WHICH ALLEGED DELAYS IN TREATMENT DUE TO CONNECTIVITY ISSUES WITH THE GEN 2 STATSTRIP METERS. NO CONTACT INFORMATION WAS PROVIDED SO FOLLOW UPS TO OBTAIN FURTHER DETAILS WERE NOT POSSIBLE. NO PRODUCT WAS RETURNED FOR ANALYSIS AND NO SPECIFIC SERIAL NUMBERS WERE PROVIDED. WITHOUT THE RETURNED PRODUCT, OR ANY SPECIFIC DETAILS, AN INVESTIGATION ON THE FAILED PRODUCT WAS NOT POSSIBLE. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

    Description of Event or Problem · 0

    PER ANONYMOUS MEDWATCH REPORT # MW5187509: "NOVA GEN 2 GLUCOMETERS WITH REPEATED ISSUES CONNECTING TO NETWORKS AND DOWNLOADING RESULTS LEADING TO MANUAL ENTRY OF RESULTS, POTENTIAL DELAYS IN CARE. METERS ARE SOMETIMES NEEDING TO BE RESET MULTIPLE TIMES CAUSING PATIENTS TO HAVE MULTIPLE SAMPLES COLLECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428902 STATSTRIP STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PZI NOVA BIOMEDICAL CORP. 2.0 00385480636858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown