BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2810305 · Received October 31, 2012

    Report

    Report Number
    2939301-2012-12517
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2012, THE LAY USER/ REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT WAS UNABLE TO TEST ON HER ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 6PM, THE REPORTER ALLEGED THE ISSUE FIRST STARTED. THE REPORTER WAS UNABLE OR UNWILLING TO REPORT IF THE PATIENT TAKES ANY MEDICATIONS TO MANAGE HER DIABETES, OR IF SHE MADE ANY CHANGES TO HER USUAL ROUTINE ON THE DAY OF THE ALLEGED ISSUE. ON AN UNKNOWN DATE AND TIME, THE REPORTER ALLEGED THE PATIENT FELT SWEATY. HOWEVER THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. WHEN THE CCA EDUCATED THE PATIENT ABOUT THE METER'S BEHAVIOR AND THE AUTO SHUT OFF FUNCTION, THE ALLEGED ISSUE REMAINED UNRESOLVED. THE CCA DETERMINED THE SUBJECT METER'S BATTERY NEEDED TO BE REPLACED; HOWEVER, THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE DUE TO THE ALLEGED ISSUE, THE REPORTER CLAIMS THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening