BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4133929 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26030
    Event Type
    Injury
    Date Received
    October 2, 2014
    Report Date
    September 22, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER DISPLAYED A BATTERY INDICATOR. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE FIRST OCCURRED AROUND DINNER TIME ON (B)(6) 2014. ACCORDING TO THE CSR¿S DOCUMENTATION, APPROXIMATELY THREE TO FOUR DAYS PRIOR TO THE ALLEGED POWER ISSUE THE PATIENT REPORTEDLY EXPERIENCED ¿EXCESSIVE THIRST¿ AND ¿HIGH BLOOD SUGARS¿. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER); HOWEVER, IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED POWER ISSUE. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND DURING HER TIME IN THE ER, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF ¿458MG/DL¿ WITH THE ER¿S METER AND WAS ADMINISTERED 35 UNITS OF LANTUS, 20 UNITS OF NOVOLOG, AND HALF A SANDWICH. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE SUBJECT METER¿S BATTERY DID NOT NEED TO BE REPLACED, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS NOT USING THE METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVERE HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615373 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3667578

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R