BEUDAMED
    FDA Adverse Event Injury Summary report: N

    010-411-01F

    MDR report key: 93255 · Received May 23, 1997

    Report

    Report Number
    2939301-1997-00039
    Event Type
    Injury
    Date Received
    May 23, 1997
    Date of Event
    April 17, 1997
    Report Date
    May 23, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER IS THE SUBJECT OF FDA RECALL.THE METER HAS BEEN EVALUATED AND MEETS FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT'S 7:30/A FASTING BLOOD GLUCOSE RESULT ON HER SURESTEP METER ON 4/17 WAS 160 MG/DL. SHE TOOK HER USUAL DOSAGE OF 1 TABLET MICRONASE (SHE DOES NOT BASE MEDICATION ON METER RESULTS). AT A REGULARLY SCHEDULED DOCTOR'S APPOINTMENT, A 9:30/A LABORATORY BLOOD GLUCOSE RESULT WAS 545 MG/DL. THE PT DENIES EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA. SHE WAS ADMITTED TO THE HOSPITAL DIRECTLY FROM THE DOCTORS OFFICE. TREATMENT PROVIDED IS UNK. THE PT WAS CONTACTED ON 5/14 FOR FOLLOW-UP. SHE HAD JUST BEEN RELEASED FROM THE HOSPITAL AFTER AN 8 DAY STAY FOR ELEVATED GLUCOSE, A CONDITION SHE WAS ALERTED TO BY HER REPLACEMENT SURESTEP METER. SHE HAS SINCE BEEN PLACED ON INSULIN. THE METER IS NOT CLEANED ACCORDING TO MFR'S RECOMMENDATIONS, DRY COTTON IS USED TO CLEAN THE METER OPTICS RATHER THAN WATER. CALIBRATION STATUS OF THE METER IS UNK AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R