BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTOUR TEST STRIPS (25)

    MDR report key: 1503754 · Received October 8, 2009

    Report

    Report Number
    1826988-2009-00890
    Event Type
    Death
    Date Received
    October 8, 2009
    Date of Event
    August 28, 2009
    Report Date
    September 24, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BAYER BRANCH WAS NOTIFIED THAT A CONTOUR LINK USER HAD DIED FROM AN INSULIN OVERDOSE. THE PT HAD RECENTLY BEGUN USING A MEDTRONIC INSULIN PUMP. THE PT ATTENDED A GROUP TRAINING SESSION WITH A MEDTRONIC SALES REPRESENTATIVE AND A NURSE EDUCATOR. SHE DID NOT BEGIN USING THE PUMP AT THAT TIME. THE MONTH PRIOR TO REPORT, THE CONTOUR LINK MEMORY CONTAINED A RESULT OF 8.9 MMOL/L (160 MG/DL) TAKEN AT 16:30. NINE DAYS LATER, PT BEGAN USING THE MEDTRONIC PUMP AFTER RETURNING TO SEE THE NURSE EDUCATOR. THE RESULTS IN THE CONTOUR LINK MEMORY FROM THAT DAY WERE 13.9 MMOL/L (250 MG/DL) AND 14.8 MMOL/L (266 MG/DL). THE FOLLOWING DAY, THE PT'S SISTER SPOKE TO HER IN THE EVENING AND SHE STATED "EVERYTHING WAS FINE." THE RESULTS IN THE CONTOUR LINK MEMORY FROM THAT DAY WERE AS FOLLOW: 66.5 MMOL/L (117 MG/DL) AT 4:44; 6.2 MMOL/L (112 MG/DL) AT 12:37; 6.8 MMOL/L (122 MG/DL) AT 15:05; 11.1 MMOL/L (199 MG/DL) AT 16:56; 8.8 MMOL/L (158 MG/DL) AT 17.49; 6.5 MMOL/L (117 MG/DL) AT 18:23. THE NEXT DAY, THE PT WAS FOUND DEAD IN THE MORNING. THE MEDTRONIC PUMP WAS RETURNED TO MEDTRONIC FOR INVESTIGATION. THE CONTOUR LINK METER HAD A READING OF 5.3 MMOL/L (96 MG/DL) IN THE MEMORY. IT'S ASSUMED THAT THIS READING WAS PERFORMED AS PART OF THE HOSPITAL'S INVESTIGATION. THE CONTOUR LINK METER AND 13 TEST STRIPS WERE RETURNED TO THE BAYER. THE METER AND 5 STRIPS WERE TESTED USING WHOLE BLOOD AND THE RESULTS WERE WITHIN SPECIFICATION. NO OTHER INFO IS KNOWN AT THIS TIME. A SUPPLEMENT WILL BE FILED IF ANY NEW INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (25) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 7KC3B31

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death