BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 11812726 · Received May 12, 2021

    Report

    Report Number
    1219029-2021-00022
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 15, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    CGL
    UDI-DI
    00385480440523
    PMA / PMN Number
    K171059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE CUSTOMER REPORTED AN INCORRECT PATIENT RESULT FOR CREATININE WAS RECEIVED WHEN RUNNING A PATIENT SAMPLE ON A STATSENSOR METER SN (B)(6). THIS OCCURRED ON APRIL 13, 2021. THE METER DID NOT INDICATE THERE WAS A PROBLEM WITH THE SAMPLE IN ANYWAY BEFORE PRODUCING THE RESULT. THE CUSTOMER INDICATED THERE WAS NO ADVERSE TREATMENT OF THE PATIENT DUE TO THE INCIDENT. THE METER WAS RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE METER WAS TESTED WITH MANUFACTURER RETAINS OF THE STRIPS WITH LOT 4920177129. ALL TESTS PASSED THE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES WHEN COMPARED TO FIVE ADDITIONAL METERS. NO DISCREPANCIES WERE OBSERVED BETWEEN BLOOD RESULTS OBTAINED BY THE RETAINED TEST STRIPS AND THE REFERENCE METHOD, SIEMENS EXL ANALYZER, WHEN USED ON THE RETURNED METER. 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 RETURNED METER AND 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. REPORT 1 OF 2.

    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 · 0

    PLEASE NOTE, THE PREVIOUS REPORT WAS DATED FOR JUNE 14TH, 2021 (06/14/2021). THIS IS AN ERROR. THE CORRECT DATE OF THE REPORT IS JUNE 15TH, 2021 (06/15/2021). REPORT 1 OF 2.

    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. PLEASE SEE REPORT 1219029-2021-00021 FOR THE FIRST FILING.

    Description of Event or Problem · 1

    NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING DISCREPANT CREATININE RESULTS USING A STATSENSOR HOSPITAL METER, SERIAL NUMBER (B)(4) AND CREATININE TEST STRIPS LOT 4920177139. IT WAS REPORTED THE PATIENT DISAGREED WITH THE INITIAL RESULTS. WHEN SAMPLES WERE RUN ON A LAB ANALYZER, THE RESULTS DID NOT MATCH THOSE OF THE METER. NO INAPPROPRIATE TREATMENT WAS STARTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULT. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707349 NOVA STATSENSOR CREATININE HOSPITAL METER CREATININE TEST SYSTEM CGL NOVA BIOMEDICAL CORP. 44052 00385480440523

    Patients

    Seq Age Sex Outcome Treatment
    1