BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2489176 · Received March 13, 2012

    Report

    Report Number
    2939301-2012-02435
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER CONTINUED TO POWER OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 9AM. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN. AT AN UNCLEAR TIME, THE PATIENT ADMINISTERED SELF AN INCREASE DOSE OF HUMALOG INSULIN (15 UNITS). ABOUT 3 HOURS AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKY, "HEAD NOT RIGHT" AND DID NOT FEEL LIKE SHE WAS PRESENT. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. IT IS NOT KNOWN IF THE PATIENT TESTED ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE BATTERIES HAVE ALREADY BEEN REPLACED IN THE SUBJECT METER. THERE IS NO INDICATION OF MISUSE. 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. 3193714

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening