BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1923436 · Received December 13, 2010

    Report

    Report Number
    2939301-2010-10678
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S LANCING DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE LANCING DEVICE INVOLVED IN THIS CASE FAILED TESTING. FOUND WITH THE LANCET HOLDER CUP BROKEN. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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) 2010, THE LAY USER/PATIENT IN THE (B)(6) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LANCET HOLDER IN HER ONETOUCH LANCING DEVICE IS BROKEN. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (TIME NOT SPECIFIED). THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH A SET DOSE OF INSULIN (TYPE OF INSULIN AND DOSAGE NOT SPECIFIED). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED LANCING DEVICE ISSUE AND THE PATIENT ALSO DENIED TESTING HER BLOOD GLUCOSE WITH ANY OTHER DEVICE. TWO DAYS LATER, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SHAKING, WEAKNESS, AND HAD DIFFICULTY IN BREATHING. AT THE ONSET OF HER SYMPTOMS, THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING SOMETHING SWEET AND DRINKING JUICE; THE PATIENT INDICATED SHE IMMEDIATELY BEGAN TO FEEL BETTER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCTS AND THE PATIENT WAS NOT USING THE ONETOUCH LANCING DEVICE FOR THE FIRST TIME. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED LANCING DEVICE ISSUE BEGAN. THE PATIENT ADMINISTERED SELF-TREATMENT WITH FOOD AND DRINK AND DID NOT RECEIVE ANY OTHER FORMS OF MEDICAL INTERVENTION.

    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