BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER STATSTRIP EXPRESS

    MDR report key: 24119161 · Received January 20, 2026

    Report

    Report Number
    MW5182501
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Report Date
    April 20, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GOOD AFTERNOON, CAN YOU PLEASE SEND THIS TO THE APPROPRIATE POINT OF CONTACT FOR MEDICAL DEVICE CONTAMINATION CONCERNS? IN ORDER TO HELP COMBAT THE SPREAD OF VIRAL INFECTIONS DUE TO CONTAMINATED GLUCOMETERS (PARTICULARLY IN EMERGENT SCENARIOS), HAS THE FDA CONSIDERED REQUIRING GLUCOMETER STRIPS TO BE INDIVIDUALLY PACKAGED OR HELD IN A CONTAINER THAT ONLY DISPENSES ONE STRIP AT A TIME? PACKAGES SUCH AS THE STATSTRIP GLUCOSE TEST STRIP ARE PACKAGED WITH THE PATIENT-CONTACT END OF THE STRIP FACING UPWARDS IN THE MULTI-USE CONTAINER. FIRST RESPONDERS WHO UTILIZE THE NOVA STATSTRIP GLUCOMETER BECAUSE IT IS FDA APPROVED FOR EMERGENCY USE CANNOT PHYSICALLY OBTAIN A SINGLE GLUCOSE STRIP FROM THE CONTAINER WITHOUT TOUCHING OTHER STRIPS. IN EMERGENT SITUATIONS, FIRST RESPONDERS' MAY NOT BE WEARING FRESH GLOVES AND IN SUCH A SCENARIO, THEY WILL UNDOUBTEDLY CONTAMINATE MANY STRIPS AT ONCE WHILE ATTEMPTING TO DISPENSE A SINGLE GLUCOSE STRIP. THE NEXT PATIENT THAT IS TESTED WITH A STRIP FROM THE CONTAINER WILL BE DIRECTLY EXPOSED TO BLOOD FROM THE PREVIOUS PATIENT(S). PER THE ARTICLE LINKED BELOW (DATED 2014), THEY RECOMMENDED: "...INFECTION CONTROL PRACTICES TO REDUCE CONTAMINATION OF BLOOD GLUCOSE TEST STRIPS OR CHANGES IN TEST STRIP PACKAGING AND TEST STRIP DISPENSING." HTTPS://PMC.NCBI.NLM.NIH.GOV/ARTICLES/PMC4975294/ FOR PATIENT SAFETY, PLEASE CONSIDER REQUIRING GLUCOMETER STRIPS (AND OTHER POINT-OF-CARE STRIPS THAT PHYSICALLY TOUCH THE PATIENT) TO BE INDIVIDUALLY PACKAGED OR HELD IN A CONTAINER THAT ONLY DISPENSES ONE STRIP AT A TIME TO PREVENT THE SPREAD OF VIRAL INFECTIONS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 4/20/2026 FOR REPORT MW5182501 TO UPDATE THE PROCODE TO PZI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174224 GLUCOMETER STATSTRIP EXPRESS PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other