BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH LANCING DEVICE

    MDR report key: 1211551 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02747
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LANCING DEVICE FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE LANCING DEVICE IS RETURNED, IT WILL BE EVALUATED AND, IF THE LANSING DEVICE DOES NOT PASS INSPECTION, FDA WILL BE INFORMED OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING THAT THE ONE TOUCH ULTRAMINI METER AND THE MINILANCER (LANCING DEVICE) WERE BROKEN AFTER HER STEPSON STOMPED ON IT IN A CONCRETE FLOOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PT. THE PT STATED THAT THE REPORTED ISSUES BEGAN ON SIX DAYS EARLIER (TIME UNK). DURING THAT TIME, SHE STATED THAT HER STEPSON STOMPED ON THE SUBJECT METER AND THE LANCING DEVICE, AND NOTED THAT THEY WERE BROKEN. THE PT REPORTEDLY DISCARDED THE BROKEN METER, LANCING DEVICE AND THE CARRYING CASE. THE PT STATED THAT SHE EXPERIENCED SYMPTOMS OF "HIGH AND LOW BLOOD SUGARS" AFTER THE REPORTED ISSUE. ON THE DAY SHE CONTACTED LFS, ON ORIGINAL DATE (AT AN UNSPECIFIED TIME), SHE REPORTEDLY "FELT HIGH" AND OBTAINED A READING OF "176 MG/DL" ON HER BACK UP METER (LFS PRODUCT). SHE REPORTEDLY DOES NOT REMEMBER THE DATE AND TIME WHEN SHE "FELT LOW" AND THE READINGS OBTAINED ON THE BACK UP METER AT THAT TIME. THE PT REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION FOR THE DIABETES. DURING THE TROUBLESHOOTING, THE CCA COULD NOT CONFIRM THE LOT NUMBER AND THE SERIAL NUMBER OF THE REPORTED PRODUCTS SINCE THE CUSTOMER REPORTEDLY DISCARDED THEM. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER. BASED UPON THE INFO PROVIDED, THERE WAS A MISUSE OF THE PRODUCT. THIS COMPLAINT IS BEING REPORTED SINCE THE PT REPORTEDLY EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AS WELL AS HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT FMK LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening