BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1970680 · Received January 25, 2011

    Report

    Report Number
    2939301-2011-00873
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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'S SPOUSE CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE PATIENT'S ONETOUCH LANCING DEVICE WAS NOT FUNCTIONING. THE REPORTER CLAIMED THAT THE LANCET DID NOT FIRE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP WITH THE REPORTER. THE PATIENT'S SPOUSE REPORTED THAT THE SUBJECT LANCING DEVICE STOPPED WORKING ON (B)(6) 2010. THE REPORTER INFORMED THE CSR THAT THE PATIENT GENERALLY TESTS HER BLOOD GLUCOSE 2 OR 3 TIMES A DAY AND MANAGES HER DIABETES WITH ORAL MEDICATION. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT'S SPOUSE CLAIMED THAT THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE; HOWEVER, REPORTED THAT THE PATIENT DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES REGIMENT. ON THE EVENING OF (B)(6) 2010, THE REPORTER STATED THAT THE PATIENT DEVELOPED SYMPTOMS OF SHAKINESS AND MEMORY LOSS; SYMPTOMS THAT WERE ASSOCIATED WITH A LOW BLOOD GLUCOSE. IN RESPONSE TO THE SYMPTOMS, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE REPORTER WAS UNABLE TO CONFIRM IF THE PATIENT'S BLOOD GLUCOSE WAS TESTED WHEN SHE ARRIVED TO THE ER. THE PATIENT'S SPOUSE CLAIMED THAT THE PATIENT WAS TREATED WITH HER USUAL DOSE OF MEDICATIONS IN ADDITION TO 'IV FLUIDS AND ANTIBIOTICS". THE REPORTER ALSO INFORMED THE CSR THAT THE PATIENT WAS HOSPITALIZED FOR 6 DAYS. THE REPORTER WAS UNABLE/UNWILLING TO CONFIRM IF THE PATIENT'S TREATMENT WAS IN RESPONSE TO LOW OR HIGH BLOOD GLUCOSE OR A DIFFERENT HEALTH CONDITION. THE DIAGNOSIS OF THE PATIENT'S HOSPITALIZATION WAS NOT PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S SPOUSE CONFIRMED THERE WAS NO MISUSE TO THE SUBJECT LANCING DEVICE. REPLACEMENT PRODUCT 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 REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND WAS TREATED BY AN HCP FOR A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    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 73 YR Hospitalization| L| R