BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEV

    MDR report key: 1832411 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07756
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (METER SERIAL # NOT PROVIDED). 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) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CAP TO HER ONETOUCH ULTRASOFT LANCING DEVICE WAS LOOSE AND/OR FALLING OFF. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON SEPTEMBER 10, 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT STATED PRIOR TO WHEN THE ISSUE STARTED SHE USED TO TEST HER BLOOD GLUCOSE AT LEAST 3X/DAY. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH INSULIN. THE PATIENT STATED THAT SHE TAKES A SET DOSE OF LANTUS MORNING AND EVENING, AND APIDRA AT MEAL TIMES (BASED ON SLIDING SCALE). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE TESTED HER BLOOD GLUCOSE 1X/DAY AS OPPOSED TO 3X/DAY AND CONSEQUENTLY ESTIMATED THE AMOUNT OF INSULIN TO TAKE BEFORE HER MEALS. ON THE AFTERNOON OF (B)(6) 2010, THE PATIENT REPORTED FEELING SHAKY, SWEATY AND HER LIPS WERE NUMB; SYMPTOMS SHE ASSOCIATED WITH A LOW BLOOD GLUCOSE. THE PATIENT STATED SHE IMMEDIATELY TREATED HERSELF WITH FOOD AND/OR DRINK AND FELT BETTER AFTERWARDS. THE PATIENT STATED SHE HAD NOT TESTED HER BLOOD GLUCOSE THAT DAY DUE TO THE ISSUE WITH HER LANCING DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO KNOWN MISUSE TO THE SUBJECT LANCING DEVICE. 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 METER 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 57 YR Life Threatening| R