BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2066351 · Received April 21, 2011

    Report

    Report Number
    2939301-2011-03303
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE WHOLE CASING TO HER ONETOUCH ULTRALINK METER WAS CRACKED/BROKEN. IT WAS DOCUMENTED THAT THE PATIENT'S DOG CHEWED UP THE SUBJECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED ISSUE BEGAN. AS PART OF HER DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON AN INSULIN PUMP. THE PATIENT STATED SHE DID NOT TAKE ANY ACTION REGARDING HER DIABETES REGIMEN AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED FEELING SWEATY, DRUNK, AND DIZZY 12 HOURS AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOMS, THE PATIENT STATED SHE DID NOT SEEK ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE PATIENT WAS NOT A FIRST TIME USER OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3037652

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening