BEUDAMED
    FDA Adverse Event Injury Summary report: N

    010-411-01F UNK

    MDR report key: 185678 · Received September 4, 1998

    Report

    Report Number
    2939301-1998-00084
    Event Type
    Injury
    Date Received
    September 4, 1998
    Date of Event
    August 7, 1998
    Report Date
    August 7, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT'S WIFE CONTACTED LIFESCAN BECAUSE SHE HAD OBTAINED ER1 ON HIS SURESTEP AND WAS INQUIRING IF THE METER NEEDED TO BE REPLACED. SHE STATED THAT ON 8/7 AT 7/A, THE SURESTEP METER READ ER1. BECAUSE SHE HAD HEARD ABOUT THE SURESTEP REPLACEMENT PROGRAM, SHE CONTACTED LIFESCAN AND WAS ASKED TO CHECK THE CONFIRMATION DOT ON THE TEST STRIP. SHE REPORTED THAT THE COLOR WAS "ALMOST BLACK." SHE WAS ADVISED TO CONTACT THE PT'S PHYSICIAN. HOWEVER, SHE WAS UNABLE TO REACH HIM. ALTHOUGH THE PT WAS UNABLE TO OBTAIN A READING, HE CONTINUED TO TAKE HIS NORMAL DOSE OF INSULIN. NO HEALTH CARE PROFESSIONAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 010-411-01F UNK * CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R