BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 7128169 · Received December 19, 2017

    Report

    Report Number
    3008382007-2017-23614
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    December 7, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008136
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE PATIENT WAS UNABLE TO BE CONTACTED, DESPITE NUMEROUS ATTEMPTS, IN ORDER TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY OCCURRED AT 5 PM ON (B)(6) 2017, HOWEVER THE PATIENT DID NOT PROVIDE THE ALLEGEDLY INACCURATE RESULT WHICH WAS OBTAINED AT THIS TIME. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH UNSPECIFIED DOSAGES OF NOVALOG AND HUMALIN R AND STATED THAT ON (B)(6) 2017 THEY HAD INCREASED THEIR DOSAGE OF HUMULIN R BY 10 UNITS. AN UNSPECIFIED PERIOD OF TIME LATER THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATINESS, CONFUSION, INCREASED HEART RATE, NUMBNESS AND TINGLING IN LEGS¿. WHILE THE PATIENT WAS ON THE INITIAL CALL WITH THE CCA AT 5:45 PM ON (B)(6) 2017 THEY WERE ON THEIR WAY TO THE HOSPITAL DUE TO DEVELOPING THESE SYMPTOMS. IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THEY RECEIVED AS A RESULT OF THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER OBTAINING ALLEGEDLY INACCURATE HIGH RESULTS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911142 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4286561 00353885008136

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening