BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3191944 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18562
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HER ONETOUCH ULTRALINK METER WAS NOT POWERING ON WHEN SHE TRIED TO TEST HER BLOOD GLUCOSE AFTER THE METER GOT WET AT AN AMUSEMENT PARK. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 IN THE EVENING. THE PATIENT REPORTED USING INSULIN PUMP THERAPY WITH HUMALOG TO MANAGE HER DIABETES. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HER NORMAL DIABETES ROUTINE DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED 2 HOURS AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿FREQUENT URINATION, THIRSTY AND HEADACHE.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 10PM SHE HAD 3.3 UNITS OF HUMALOG INSULIN. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE ON ANOTHER DEVICE. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294246 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3435821

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R