BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3230890 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20144
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO TEST BECAUSE HER ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 IN THE AFTERNOON. THE PATIENT REPORTED USING NON ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 IN THE AFTERNOON SHE HAD SOMETHING MORE TO EAT OR DRINK. THE PATIENT REPORTED 35 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿BLURRED VISION AND SWEATING¿. IT IS UNCLEAR IF THE PATIENT ASSOCIATES THE SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER SYMPTOMS. 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. THE PATIENT WAS EDUCATED REGARDING THE METER¿S AUTO SHUT OFF FUNCTION BUT THE ALLEGED ISSUE REMAINED UNRESOLVED. THE SUBJECT METER¿S BATTERY WAS FOUND TO BE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF AN ACUTE COMPLICATION OF DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332175 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3432580

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening