BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3943193 · Received July 18, 2014

    Report

    Report Number
    2939301-2014-17829
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 13, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THEIR ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE POWER ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2014. THE PATIENT INFORMED THE CCA THAT THEY MANAGE THEIR DIABETES WITH ORAL MEDICATION AND INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AFTER ALLEGED METER POWER ISSUE STARTED. THE PATIENT REPORTED THAT THEY DEVELOPED SYMPTOMS OF ¿FREQUENT URINATION AND DIZZY¿ ONE DAY AFTER THE POWER ISSUE BEGAN. THE PATIENT REPORTED THEY WENT TO THE ER ON EITHER (B)(6) 2014. DURING THE ER VISIT, THE PATIENT CONFIRMED THEIR BLOOD GLUCOSE WAS TESTED WITH AN ER/HOSPITAL METER AND RESULT WAS ¿551 MG/DL¿. THE PATIENT CLAIMED THEY WERE TREATED WITH IV FLUIDS AND INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED METER POWER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421370 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3584990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R