BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 3202089 · Received June 27, 2013

    Report

    Report Number
    1219029-2013-00003
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGA
    PMA / PMN Number
    K063821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER NOVA BIOMEDICAL DISCUSSED THE ISSUE WITH HOSP MANAGEMENT, THE FOLLOWING ACTIONS EITHER HAVE BEEN, OR WILL BE PUT IN PLACE; HOSPITAL POLICY REGARDING INSULIN DOSING HAS BEEN AMENDED TO INCLUDE THE FOLLOWING; NO INSULIN DOSING DECISIONS SHALL BE MADE FROM "HISTORICAL" DATA. HISTORICAL DATA IS DEFINED AS ANY PT RESULT INFO FROM THE METERS THAT IS OBTAINED FROM ANY INFO SYSTEM. DOSING DETERMINATIONS SHALL ONLY BE MADE BASED ON PT RESULT INFO TAKEN DIRECTLY FROM THE METER AT THE TIME OF TESTING. THE INFO SYSTEM CONFIGURATION WILL BE CHANGED TO QUEUE SAMPLES WITH DATE/TIME STAMPS THAT ARE EITHER ANY TIME IN THE FUTURE, OR OLDER THAN X NUMBER OF HOURS IN THE PAST, RELATIVE TO LOCAL SYSTEM TIME. (X = THE NUMBER OF HOURS AND IS TBD BY HOSP POC STAFF.) METER CONFIGURATION WILL BE CHANGED TO ONLY ALLOW SUPERVISOR PRIVILEGED OPERATORS TO PERFORM A DATE/TIME CHANGE ON THE METER.

    Description of Event or Problem · 1

    PER THE END USER, PT RESULT TIME IN THEIR HOSPITAL INFO SYSTEM WAS TWO HOURS BEFORE THE COLLECTION TIME. PER THE END USER, THIS CAUSED THE PT TO BE GIVEN AN INCORRECT DOSE OF INSULIN. DETERMINED THROUGH DISCUSSION WITH THE END USER BY NOVA BIOMEDICAL PERSONNEL THAT THE EVENTS LEADING TO THE INCIDENT WERE CONFIRMED TO BE THE GLUCOSE METER BATTERY LOST POWER, THE BATTERY WAS REPLACED BY THE OPERATOR, THE TIME ON THE METER WAS SET INCORRECTLY BY THE OPERATOR, THE AFFECTED METER WAS DOCKED BUT DID NOT COMMUNICATE TO THE HOSP INFO SYSTEM, THE OPERATOR UNDOCKED METER AT SOME POINT AND THE INCORRECTLY ENTERED TIME WAS STILL ON METER AND PT TESTS WERE RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293200 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM CGA - GLUCOSE TEST SYSTEM CGA NOVA BIOMEDICAL 44993

    Patients

    Seq Age Sex Outcome Treatment
    1