BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 5541401 · Received April 1, 2016

    Report

    Report Number
    1052693-2016-00655
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 9, 2016
    Report Date
    April 14, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND ON RETURNED METER AND TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER IS CALLING COMPLAINING OF HIGH BLOOD GLUCOSE RESULTS ON FATHER'S METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS LESS THAN 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CURRENTLY TAKING MEDICATION / INSULIN TO MANAGE DIABETES. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 354 MG/DL AND 394 MG/DL. THE PRODUCT IS STORED IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/24/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 230MG/DL, (B)(6) 2016 06:30AM, FASTING: YES. 207MG/DL, (B)(6) 2016 06:30AM, FASTING: YES. 230MG/DL, (B)(6) 2016 06:30AM, FASTING: YES. 234MG/DL, (B)(6) 2016 06:30AM, FASTING: YES. 296MG/DL, (B)(6) 2016 06:30AM, FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER IS CALLING COMPLAINING OF HIGH BLOOD GLUCOSE RESULTS ON FATHER'S METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS LESS THAN 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CURRENTLY TAKING MEDICATION / INSULIN TO MANAGE DIABETES. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 354 MG/DL AND 394 MG/DL. THE PRODUCT IS STORED IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/24/2018 AND OPEN VIAL DATE IS 02/18/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198677 SIDEKICK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. SIDEKICK SS4787

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR