BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICOMPASS CONNECT

    MDR report key: 1150091 · Received August 29, 2008

    Report

    Report Number
    2032583-2008-00001
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 26, 2008
    Manufacturer
    IMETRIKUS, INC.
    Product Code
    LNX
    PMA / PMN Number
    K0427468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INDICATIONS FOR USE: MEDICOMPASS CONNECT SERVES AS AN INTERFACE OR A GATEWAY BETWEEN PERSONAL MONITORING DEVICES AND A GENERAL PURPOSE HEALTH MANAGEMENT DATABASE. MONITORING DEVICES THAT CAN INTERFACE TO THE MEDICOMPASS CONNECT INCLUDE, BUT ARE NOT LIMITED TO: BLOOD GLUCOSE MONITORS, BLOOD PRESSURE CUFFS, INSULIN PUMPS, SPIROMETERS, SCALES. MEDICOMPASS CONNECT IS DESIGNED FOR PROFESSIONAL HEALTHCARE SETTINGS AND HOME USE. A SCHEDULED SOFTWARE UPDATE THAT WAS DEPLOYED 5 DAYS PRIOR TO THE REFERENCED PRIOR TO THE REFERENCED PRODUCT COMPLAINT WAS DETERMINED TO THE SOURCE OF THE ERROR. THE UPDATE WAS UNINSTALLED IMMEDIATELY UPON LEARNING OF THE COMPLAINT. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED AFTER THE UNINSTALL, WHICH OCCURRED IN 2008.

    Description of Event or Problem · 1

    COMPANY RECEIVED A COMPLAINT FROM A CUSTOMER (E.1) REPORTING THAT A PATIENT'S SOFTWARE RECORDS WERE MISSING BLOOD GLUCOSE DATA FROM A PERSONAL HEALTH MONITORING DEVICE. THIS COMPLAINT LED TO AN INVESTIGATION BY THE COMPANY TO DETERMINE THE EXTENT OF THE OCCURRENCE. THE INVESTIGATION DISCOVERED A RELATED INCIDENT WHEREBY 4 PATIENT RECORDS HAD RECEIVED ERRONEOUS DATA FROM PERSONAL HEALTH MONITORING DEVICES OTHER THAN THAT OF THE INTENDED PATIENT. UPON DISCUSSIONS WITH THE HEALTH CARE PROFESSIONALS INVOLVED WITH THESE 4 PATIENTS, IT WAS LEARNED THAT 1 PATIENT HAD THEIR ORAL DIABETES MEDICATION CHANGED AS A RESULT OF RECEIVING THE ERRONEOUS DATA. A CLINICAL REVIEW OF THE PATIENT'S DATA, PRE AND POST MEDICATION CHANGE INDICATED NO ADVERSE EFFECT TO THEIR BLOOD GLUCOSE LEVELS. IN REGARDS TO THE OTHER 3 PATIENTS, NO CHANGE IN THEIR MEDICATIONS WAS INITIATED BY THE HEALTH CARE PROFESSIONALS AS A RESULT OF RECEIVING ANY ERRONEOUS DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICOMPASS CONNECT PHYSIOLOGICAL SIGNAL TRANSMITTER/REC LNX IMETRIKUS, INC. MLCLN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK