BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1984433 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00002
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 2, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED READING OF 112, 140 MG/DL. HE DOUBTED THE READINGS, SO HE RETESTED AND RECEIVED A READING OF 149 MG/DL. THE CUSTOMER THOUGHT THE READINGS WERE HIGH, SO HE TOOK 13 UNITS OF INSULIN. AFTER A FEW MINUTES, HE BECAME INCOHERENT AND WAS SWEATING PROFUSELY. HE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER COULD NOT RECALL THE BLOOD GLUCOSE READING THE HOSPITAL RECEIVED, BUT HE THOUGHT IT WAS AROUND 50 MG/DL. HE STATED THAT HE DID NOT RECEIVE TREATMENT AND WAS SENT HOME AFTER A FEW HOURS. THE CUSTOMER RETURNED HIS TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE WENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 0FC3A02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization