BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 3000932 · Received March 13, 2013

    Report

    Report Number
    3008382007-2013-04806
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE DEPTH ADJUSTOR ON THE PATIENT'S ONETOUCH LANCING DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS; HOWEVER, ON (B)(6) 2013, THE PATIENT REPORTEDLY TOOK LESS FOOD AND/ OR DRINK. THAT SAME DAY, THE REPORTER CLAIMS THE PATIENT HAD SYMPTOMS OF THIRSTY, WEAKNESS AND WAS TAKING NAPS. THE REPORTER DENIED THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT LANCETS WERE BEING USED AND THERE WAS NO INDICATION OF MISUSE. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER NOT BEING ABLE TO TEST DUE TO THE LANCING DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105405 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening