BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1932251 · Received December 17, 2010

    Report

    Report Number
    2939301-2010-10840
    Event Type
    Injury
    Date Received
    December 17, 2010
    Report Date
    December 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH LANCING DEVICE WOULD NOT FIRE. ON (B)(6) 2010, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6). THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT STATED SHE SKIPPED HER USUAL DOSE OF MEDICATION. ABOUT 24 HOURS AFTER THE ALLEGED PRODUCT ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF "LOW BLOOD SUGAR, BLURRY VISION, DIZZINESS, NAUSEATED AND WEAK LEGS." THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT LANCING DEVICE. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER NOT BEING ABLE TO TEST DUE TO A BROKEN LANCING DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening