BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE METER SYSTEM

    MDR report key: 11809037 · Received May 11, 2021

    Report

    Report Number
    1219029-2021-00020
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 11, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    PZI
    UDI-DI
    00385480533980
    PMA / PMN Number
    K181043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE HAS NOT RETURNED TO NOVA AS OF YET; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS BEING COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON (B)(6) ON THE STATSTRIP 1.75 METER SN: (B)(4) AND A FLOW ERROR OCCURRED. IT WAS RERUN AND WAS LESS THAN 10, A DRAW WAS DONE AND IT WAS 532. THE PATIENT WAS MOVED TO ANOTHER FLOOR AND TESTED WITH ANOTHER METER AND RECEIVED GOOD RESULTS. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701483 STATSTRIP GLUCOSE METER SYSTEM BLOOD GLUCOSE METER PZI NOVA BIOMEDICAL CORP 53398 00385480533980

    Patients

    Seq Age Sex Outcome Treatment
    1