BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 10985011 · Received December 10, 2020

    Report

    Report Number
    1219029-2020-00052
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 1, 2020
    Report Date
    December 10, 2020
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    PZI
    UDI-DI
    00385480547901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE CUSTOMER IS LOCATED IN (B)(6) WHERE THE METER PART NUMBER IS 54794. AS THE MANUFACTURER, A SIMILAR DEVICE PART NUMBER FOR THE US TO REPORT IS 54790. THEREFORE, THIS REPORT IS BEING SUBMITTED TO THE FDA UNDER 54790 AND THE SUBSEQUENT REPORT TO HEALTH (B)(6) WILL REFLECT 54794. THE CUSTOMER REPORTED THAT THERE WAS A BARCODE MISREAD ON A STATSTRIP METER. THE FACILITY REPORTED THAT THE METER SCANNED A PATIENT BARCODE IN THE EMERGENCY DEPARTMENT, HOWEVER WAS UNSUCCESSFUL IN OBTAINING ACCURATE DETAILS OF THE DISCREPANT READ. THE CUSTOMER STATED THAT THE INFORMATION WAS DETAINED IN THEIR SYSTEM AND THEY WERE UNABLE TO DETERMINE WHO THE PATIENT WAS AND UNABLE TO OBTAIN THE ARMBAND. THE FACILITY IS CONTINUING TO UTILIZE THE METER, THEREFORE; NO SAMPLE WAS RETURNED TO NOVA FOR EVALUATION. THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE ANALYZER WAS PERFORMED BY THE INVESTIGATOR. THE REVIEW INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE PRODUCTS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHRS INDICATED THAT THE RELEASED PRODUCT MET ALL SPECIFICATIONS. PREVIOUSLY OPENED AND INVESTIGATED INCIDENTS FROM THE CUSTOMER FACILITY DETERMINED THAT THE ROOT CAUSE FOR THE PATIENT MISREADS IS ATTRIBUTED TO THE USER FACILITY USING POOR QUALITY 1D BARCODES THAT WERE PRINTED USING CODE -39 SYMBOLOGY. CODE-39 IS NO LONGER INDUSTRY STANDARD, AND HAS A HIGHER SUBSTITUTION FAILURE RATE THAN CODE-128 AND MUCH HIGHER THAN THE STANDARD 2D BARCODES AVAILABLE. THIS FAILURE MODE DOES NOT REPRESENT A SYSTEMIC ISSUE OR A FAILURE OF THE METER TO PERFORM AS INTENDED. THE FAILURE MODE IS DIRECTLY RELATED TO THE QUALITY OF THE BARCODE BEING GENERATED BY THE CUSTOMER. THE ROOT CAUSE OF THE MISREAD IS MOST LIKELY DUE TO POOR BARCODE QUALITY. BASED ON THE ORIGINAL INVESTIGATION, NOVA SUGGESTED TO PREVENT BARCODE MIS-READS IN THE FUTURE, THAT THE CUSTOMER SHOULD CHANGE FROM A 1D TO A 2D BARCODE, WHICH WOULD GREATLY REDUCE THE CHANCES OF A BARCODE MISREAD. TRENDING WILL BE MONITORED FOR THIS AND OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A BARCODE MISREAD ON A STATSTRIP METER. THE FACILITY REPORTED THAT THE METER SCANNED A PATIENT BARCODE IN THE EMERGENCY DEPARTMENT, HOWEVER WAS UNSUCCESSFUL IN OBTAINING ACCURATE DETAILS OF THE DISCREPANT READ. THE CUSTOMER STATED THAT THE INFORMATION WAS DETAINED IN THEIR SYSTEM AND THEY WERE UNABLE TO DETERMINE WHO THE PATIENT WAS AND UNABLE TO OBTAIN THE ARMBAND. THE FACILITY IS CONTINUING TO UTILIZE THE METER, THEREFORE; NO SAMPLE WAS RETURNED TO NOVA FOR EVALUATION. THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446672 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM BLOOD GLUCOSE METER PZI NOVA BIOMEDICAL CORP 54794 00385480547901

    Patients

    Seq Age Sex Outcome Treatment
    1