BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRALINK METER

    MDR report key: 1163079 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02244
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON AUGUST 28, 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATE HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PT. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN 5 DAYS PRIOR TO CONTACTING LFS. ON THAT DAY AT 6:23 PM, THE PT REPORTED OBTAINING A READING OF "409 MG/DL" ON THE SUBJECT METER. BASED ON THAT READING, THE PT CLAIMED SHE ADMINISTERED 5.2 UNITS OF HUMALOG INSULIN (BASED ON A SLIDING SCALE). APPROXIMATELY 10-15 MINUTES AFTER TAKING THE INSULIN, SHE REPORTED, BECOMING SYMPTOMATIC. THE PT STATED SHE FELT "TERRIBLE" AND COULD NOT "THINK, TALK, OR MOVE." IT IS UNKNOWN HOW LONG THE PT WAS EXPERIENCING THESE SYMPTOMS. HOWEVER, SHE MENTIONED ONCE SHE COULD COMMUNICATE SHE ATE COOKIES AND STARTED TO FEEL BETTER. THE PT ALSO STATED THAT HER HUSBAND CARRIES EMERGENCY GLUCAGON, BUT IT IS UNCLEAR IF HER HUSBAND ADMINISTERED THAT TREATMENT TO THE PT AT THE TIME OF SYMPTOMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R