BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1211554 · Received October 22, 2008

    Report

    Report Number
    2939301-2008-02746
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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 METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING THAT THE ONETOUCH 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 PATIENT. THE PATIENT STATED THAT THE REPORTED ISSUES BEGAN ON SIX DAYS EARLIER (TIME UNKNOWN). DURING THAT TIME, SHE STATED THAT HER STEPSON STOMPED ON THE SUBJECT METER AND THE LANCING DEVICE, AND NOTED THAT THEY WERE BROKEN. THE PATIENT REPORTEDLY DISCARDED THE BROKEN METER, LANCING DEVICE AND THE CARRYING CASE. THE PATIENT STATED THAT SHE EXPERIENCED SYMPTOMS OF "HIGH AND LOW BLOOD SUGARS" AFTER THE REPORTED ISSUE. ON THE DAY SHE CONTACTED LFS, (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 PATIENT 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 INFORMATION PROVIDED, THERE WAS A MISUSE OF THE PRODUCT. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AS WELL AS HYPOGLYCEMIA AFTER THE REPORTED ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening