BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR LINK

    MDR report key: 2990015 · Received March 5, 2013

    Report

    Report Number
    1826988-2013-00051
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ABOUT THE EVENT AFTER THE INITIAL REPORT: OUTCOME ATTRIBUTED TO THE ADVERSE EVENT, DESCRIPTION OF EVENT OR PROBLEM, CORRECTED DATE OF EVENT.

    Additional Manufacturer Narrative · 1

    THE MODEL # WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS IN SO COMPLETE INFORMATION WAS NOT GIVEN.

    Description of Event or Problem · 1

    THE CUSTOMER MEASURED HIS BLOOD GLUCOSE ON THE CONTOUR LINK METER AT APPROXIMATELY 4:00PM AND RECEIVED A READING OF 86MG/DL. HE THEN ATE DINNER AND RE-TESTED HIS BLOOD. THE READING WAS 140MG/DL AND HE INJECTED APPROXIMATELY 12UNITS OF NOVORAPID INSULIN. HE FELL ASLEEP AT APPROXIMATELY 6:00PM AND ABOUT 1 HOUR LATER WAS AWAKENED BY HIS GIRLFRIEND BECAUSE HE WAS SWEATING PROFUSELY. THE CUSTOMER RAN ANOTHER BLOOD TEST AND THE READING WAS 40MG/DL. THE GIRLFRIEND GAVE HIM PURE GLUCOSE DROPS, BUT THE CUSTOMER WAS UNCONSCIOUS AND CRAMPING. AS A RESULT OF THE CRAMPING THE CUSTOMER BROKE HIS UPPER ARM (TUBERCULUM). THE PARAMEDICS WERE CALLED AND THEY INJECTED A GLUCOSE SOLUTION. THE CUSTOMER WAS TAKEN TO THE HOSPITAL FOR THE HYPOGLYCEMIA AND ULTIMATELY TO HAVE SURGERY ON HIS ARM; TWO SCREWS WERE SECURED INTO THE TUBERCULUM. HE REMAINED IN THE HOSPITAL FOR FOUR DAYS.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER, AT DINNER, RECEIVED A BLOOD GLUCOSE READING OF 140MG/DLL ON THE CONTOUR LINK AND INJECTED INSULIN ACCORDINGLY. HE LATER WOKE UP FROM SLEEPING WITH HYPOGLYCEMIC SYMPTOMS, TESTED HIS BLOOD AND THE READING WAS 40MG/DL. FURTHER INFORMATION ABOUT THE INCIDENT WAS NOT PROVIDED. ONLY THE METER INFORMATION WAS PROVIDED. IT WAS ASKED THAT THE CUSTOMER RETURN THE TEST STRIPS FOR EVALUATION. HE WAS SENT A NEW METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94264 CONTOUR LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R