BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 11507402 · Received March 17, 2021

    Report

    Report Number
    1219029-2021-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 12, 2021
    Report Date
    May 13, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    CGA
    UDI-DI
    00385480533980
    PMA / PMN Number
    K063821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED AN INCORRECT ACCOUNT NUMBER SHOWN WHEN SCANNED BY THE STATSTRIP 1.75 METER SN (B)(6). THE METER SCANNED A PATIENT IDENTIFICATION NUMBER HOWEVER; RECEIVED INCORRECT OUTPUT THAT DID NOT MATCH. THE CUSTOMER STATES THEY ARE UNAWARE OF ANY PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY. TO DATE, THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. WITHOUT THE RETURNED PRODUCT A DETAILED INVESTIGATION ON THE FAILED PRODUCT COULD NOT BE PERFORMED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE STATSTRIP METER SN (B)(6) WAS PERFORMED BY A QUALITY CONTROL ENGINEER. THE REVIEW INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE PRODUCTS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO NOVA FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) IS NOT REQUIRED AS A RESULT OF THIS INVESTIGATION BECAUSE THE COMPLAINT WAS NOT CONFIRMED. NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE, NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND CORRECTED INFORMATION: B4, D9, G6, H1, H2, H3, H10. 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 WAS NO REPORTED PATIENT HARM OR INTERVENTION. THERE IS CURRENTLY A PENDING INVESTIGATION. A REQUEST HAS BEEN SENT TO THE CUSTOMER OBTAIN METERS AND BARCODE OR SAMPLE OF A TEST BARCODE FOR VERIFICATION OF 1-D VERSUS 2-D BARCODES. ADDITIONAL INFORMATION AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT GLUC CONN METERS (1.75) MIS-SCANNING 1D BAR SHOWING INCORRECT PATIENT ID'S. THE ACCOUNT HAS 1 & 2 D BAR CODES ON PATIENTS WRISTS. THERE HAS BEEN NO REPORT OF PATIENT HARM OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403726 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM BLOOD GLUCOSE METER CGA NOVA BIOMEDICAL CORP 53398 00385480533980

    Patients

    Seq Age Sex Outcome Treatment
    1