BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSENSOR CRETININE HOSPITAL METER SYSTEM

    MDR report key: 12041582 · Received June 22, 2021

    Report

    Report Number
    1219029-2021-00025
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    CGL
    UDI-DI
    00385480453356
    PMA / PMN Number
    K171059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE CUSTOMER REPORTED AN INCORRECT RESULT WAS RECEIVED FOR CREATININE WHILE RUNNING A PATIENT SAMPLE ON A STATSENSOR METER, SERIAL NUMBER (B)(6) WITH TEST STRIP LOT 4920227129. THIS EVENT OCCURRED ON MAY 19, 2021. THE CUSTOMER STATED THE METER HAD PASSED THE QUALITY CONTROL REQUIREMENTS FOR CREATININE. THE METER WAS RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE TESTING STRIPS USED BY THE CUSTOMER WERE NOT RETURNED TO THE MANUFACTURER. MANUFACTURER RETAINS OF STRIP LOT 4920227129 WERE UNAVAILABLE FOR TESTING. AS A RESULT, STRIP LOT 4920279129, THE OLDEST AVAILABLE LOT, WAS USED FOR THE INVESTIGATION IN PLACE OF THE CUSTOMER STRIPS. THESE STRIPS WERE TESTED ACROSS FIVE NOVA BIOMEDICAL METERS ALONG WITH THE RETURNED CUSTOMER METER. ALL TESTS PASSED THE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES. NO DISCREPANCIES WERE OBSERVED BETWEEN BLOOD RESULTS OBTAINED BY THE RETURNED METER, THE MANUFACTURER METERS, AND THE REFERENCE ANALYZER WHEN COMPARED. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE METER AND THE STRIP LOT BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE METER AND TEST STRIP BATCH. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AFTER TESTING THE MANUFACTURER RETAINS OF STRIP LOT 4920279129, THE OLDEST LOT AVAILABLE, AND THE RETURNED CUSTOMER METER. A ROOT CAUSE WHICH LEAD TO THE INITIAL COMPLAINT COULD NOT BE IDENTIFIED, AND NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B4, D9, G3, G6, H2, H10. PRODUCT WAS RECEIVED FOR EVALUATION ON 07-19-21. AN INVESTIGATION HAS BEEN INITIATED AND IS CURRENTLY PENDING. FURTHER DETAILS WILL BE PROVIDED IN AN ADDITIONAL SUPPLEMENTAL REPORT WHEN THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS REPORT TWO OF TWO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON THE STATSENSOR METER SERIAL NUMBER (B)(4) WITH TEST STRIP LOT 4920227129, AND THE EGFR WAS RUNNING LOW FOR THE PATIENT. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936474 NOVA STATSENSOR CRETININE HOSPITAL METER SYSTEM CREATININE TEST SYSTEM CGL NOVA BIOMEDICAL CORP. 45335 00385480453356

    Patients

    Seq Age Sex Outcome Treatment
    1