BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 2001587 · Received February 25, 2011

    Report

    Report Number
    2954323-2011-01736
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE CUSTOMER WAS REPORTEDLY USING INCORRECT TEST STRIPS WITH HER INSULIN PUMP AND THE CUSTOMER WAS EDUCATED ABOUT THE CORRECT PRODUCT TO PURCHASE FOR HER INSULIN DELIVERY SYSTEM. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO PRODUCT INVESTIGATION IS REQUIRED. THIS IS THE FINAL REPORT. NOTE: THE DATE OF THE EVENT IS UNKNOWN. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE WAS HOSPITALIZED AND RECEIVED MEDICAL TREATMENT DUE TO USING INCORRECT TEST STRIPS WITH HER OMNIPOD INSULIN PUMP, AND ALSO DUE TO OTHER UNKNOWN FACTORS. THE FOLLOWING OMNI TEST STRIP LOTS WERE REPORTED: 1032409, 1021704 AND 1022709. THE CUSTOMER REPORTEDLY REFUSED TO COMPLETE THE MEDICAL TROUBLESHOOTING SURVEY QUESTIONS AT THE TIME OF THE CALL AND LATER ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO COMPLETE THE REFERRED SURVEY WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM NBW 1032409, 1021704

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization