BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TS

    MDR report key: 2161197 · Received July 8, 2011

    Report

    Report Number
    1826988-2011-00400
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE U.S., CUSTOMER INFO IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) CONTACTED CUSTOMER SERVICE ABOUT HIS CONTOUR TS METER. HE ALLEGED THAT HE TESTED HIS FASTING BLOOD GLUCOSE AND RECEIVED A READING OF 541 MG/DL. HE TOOK 8 UNITS OF INSULIN BASED ON THE READING AND BECAME HYPOGLYCEMIC. HE ATE SOMETHING SWEET AND RECOVERED IN ABOUT 20-30 MINUTES. ON THE SAME DAY, THE CUSTOMER RECEIVED A READING OF 278 MG/DL USING HIS CONTOUR TS METER, WHILE 2 OTHER METERS READ 102 AND 98 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS NBW BAYER HEALTHCARE LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention