BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 11813609 · Received May 12, 2021

    Report

    Report Number
    1219029-2021-00019
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 25, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    CGL
    PMA / PMN Number
    K070068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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). THIS OCCURRED ON (B)(6) 2021. THE METER DID NOT INDICATE THERE WAS A PROBLEM WITH THE SAMPLE OR THE RESULT IN ANYWAY. THE CUSTOMER INDICATED THE PATIENT DID NOT RECEIVE CT CONTRAST FOR AN UPCOMING CT SCAN BECAUSE OF THE CREATININE RESULTS FROM THEIR LAB ANALYZER. A CONCERN WAS EXPRESSED THAT THE METER PRODUCED A VALUE TOO LOW WHEN COMPARED TO THE ANALYZER. NO OTHER TREATMENTS FOR THE PATIENT WERE AFFECTED. THE METER WAS NOT RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. AS A RESULT, RETAINS OF THE TEST STRIP LOT 4920279129 WERE USED ACROSS FIVED DIFFERENT NOVA METERS. ALL TESTS PASSED THE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES. NO DISCREPANCIES WERE OBSERVED BETWEEN BLOOD RESULTS OBTAINED BY THE RETAINED TEST STRIPS AND THE REFERENCE METHOD, SIEMENS EXL ANALYZER, WHEN USED. 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 THE STRIPS. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, AND NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED AND IS STILL 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DISCREPANT CREATINE RESULT WAS REPORTED WHEN USING A STATSENSOR HOSPITAL METER AND CREATININE TEST STRIPS , LOT 4920279129. THE PATIENT WAS BEING PREPPED FOR A CT SCAN WITH CONTRAST, HOWEVER; THE SAMPLE RESULT OF 1.6 WAS OBTAINED ON THE METER AND LAB REPORTED A RESULT OF 2.46 PRIOR TO THE CONTRAST BEING ADMINISTERED. THERE WAS NO CONTRAST GIVEN TO THE PATIENT NOR WAS THERE ANY PATIENT HARM OR INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711433 NOVA STATSENSOR CREATININE HOSPITAL METER CREATININE TEST SYSTEM CGL NOVA BIOMEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR