BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3943366 · Received July 18, 2014

    Report

    Report Number
    2939301-2014-17828
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 12, 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
    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 A FEW DAYS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT THEY MANAGE THEIR DIABETES WITH ORAL MEDICATION AND INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT REGIMEN DUE TO METER ISSUE. HOWEVER, REPORTED THAT 2 DAYS AFTER THE POWER ISSUE STARTED, THEY DEVELOPED SYMPTOMS OF ¿DRY MOUTH, BLURRY EYES, FREQUENT URINATION, AND FEELING DIZZY¿. THE PATIENT REPORTED THEY WENT TO THE ER ON (B)(6) 2014. DURING THE ER VISIT, THE PATIENT CONFIRMED THEIR BLOOD GLUCOSE WAS TESTED WITH AN ER/HOSPITAL METER AND RESULT WAS ¿OVER 400 MG/DL¿. THE PATIENT CLAIMED THEY WERE TREATED WITH HUMALOG INSULIN (DOSE UNKNOWN) BY HCP. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THERE NO APPARENT MISUSE OF THE PRODUCT AND THAT THE METER¿S BATTERY DID NOT NEED TO BE REPLACED PER THE OWNER¿S BOOKLET RECOMMENDATION. THE ALLEGED ISSUE REMAINED UNRESOLVED. 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
    422753 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R