BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEV

    MDR report key: 1981796 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01205
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASOFT LANCING DEVICE CAP WAS BROKEN. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS 2-4 TIMES DAILY AND MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 500MG) TWICE DAILY AND INSULIN (LANTUS 5 UNITS) AT BEDTIME IF HER RESULTS ARE OVER "98 MG/DL". THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE SKIPPED HER DOSE OF MEDICATION, SINCE SHE WAS NOT ABLE TO TEST HER BLOOD SUGAR. THE PATIENT REPORTED SHE WAS FEELING SLEEPY AND HANDS WERE SHAKY A WEEK AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE PATIENT, AT FIRST SHE THOUGHT SHE WAS FEELING HIGH SO SHE DRANK WATER, AND WHEN SHE DID NOT FEEL ANY BETTER SHE THOUGHT SHE WAS FEELING LOW, SO SHE DRANK ORANGE JUICE. WHEN HER SYMPTOMS DID NOT GO AWAY, THE PATIENT STATED SHE TOOK A NAP FOR 2 HOURS AND WHEN SHE WOKE UP SHE WAS FEELING BETTER. THE PATIENT CLAIMED SHE ATTEMPTED TO USE THE LANCING DEVICE BUT THE CAP KEPT FALLING OFF. THE PATIENT STATED SHE DID NOT HAVE ANOTHER LANCING DEVICE TO USE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THERE WAS NO MISUSE OF THE LANCING DEVICE AND THE PATIENT WAS USING THE CORRECT CAP. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEV GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R