BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 1030028 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00560
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 31, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LANCING DEVICE FOR EVAL, BUT HAS NOT YET REC'D THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM, AND IF THE STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT. D4: LOT # WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE COMPLAINT IS CLASSIFIED BASED UPON INFO THE RPTR/LAYPERSON GAVE THE CUSTOMER CARE ADVOCATE, CCA, ON MARCH 31, 2008. BECAUSE THE PHONE # GIVEN TO THE CCA IS INCORRECT, THIS SENIOR MEDICAL AFFAIRS SPECIALIST WILL MAIL A LETTER TO THE PT TO OBTAIN INFO. THE RPTR COMPLAINED THAT THE THREADS ON THE PT'S ONETOUCH ULTRASOFT LANCING DEVICE WERE DAMAGED. THE ALLEGED ISSUE WAS OBSERVED IN 2008. FOUR DAYS LATER, AT APPROX 8:00 PM, THE PT WAS TAKEN TO THE ER WITH DIZZINESS. IN THE ER, THE PT WAS GIVEN IV FLUIDS AFTER A BLOOD GLUCOSE RESULT OF 738 MG/DL WAS OBTAINED AND RELEASED FOUR HRS LATER. ALTHOUGH IT IS UNK WHETHER THE PT HAD OBTAINED BLOOD SAMPLES WITH ANOTHER LANCING DEVICE IN ORDER TO TEST BETWEEN THE FIVE DAYS OR HOW THE PT MANAGED HIS DIABETES, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT AS THE RPTR INDICATED THE PT WAS TREATED IN THE ER WITH IV FLUIDS AND A HIGH BLOOD GLUCOSE RESULT WAS ALSO OBTAINED. IF THE PT RESPONDS TO THIS SPECIALIST'S LETTER, A SUPPLEMENT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R