BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2220742 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07908
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    August 18, 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. THE 510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAMINI METER WOULD NOT POWER ON, AND THE ONETOUCH DELICA LANCING DEVICE WOULD NOT FIRE THE LANCET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. ON (B)(4) 2011 THE TSR MAILED A LETTER REQUESTING THE PATIENT CONTACT MEDICAL SURVEILLANCE. THE PATIENT REPORTED THAT FOR TWO WEEKS, THE REPORTED METER WOULD INTERMITTENTLY NOT POWER ON, AND THE REPORTED LANCING DEVICE WOULD INTERMITTENTLY NOT FIRE. ON AN UNSPECIFIED DATE, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. IT IS NOT CLEAR IF THE METER POWER ISSUE OCCURRED, OR THE LANCING DEVICE ISSUE OCCURRED, OR BOTH, PRIOR TO THE ONSET OF SYMPTOMS. TEN TO TWELVE HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF FATIGUE AND FREQUENT URINATION AND SHE FELT HER BLOOD GLUCOSE LEVEL WAS HIGH. THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING 28 UNITS INSULIN; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT, AND THE METER WOULD POWER ON WITH THE POWER BUTTON. THE METER, TEST STRIPS AND LANCING DEVICE WERE REPLACED. IT IS NOT KNOWN IF THE PATIENT WAS ABLE TO OBTAIN A BLOOD SAMPLE AND TEST HER BLOOD GLUCOSE LEVEL PRIOR TO THE ONSET OF SYMPTOMS. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE AND/OR THE LANCING DEVICE ISSUE, AND RECEIVED TREATMENT WITH INSULIN. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3148683

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R