BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2042640 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02847
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HE WAS UNABLE TO CODE HIS ONETOUCH ULTRALINK METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 (BETWEEN 8-9PM). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT CONSUMED MORE FOOD/DRINK JUST AFTER THE ALLEGED ISSUE OCCURRED AT 8AM). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF SHAKING AND SWEATING 20 TO 30 MINUTES LATER; HOWEVER, PER CSR NOTES, ON (B)(6) 2011 (TIME NOT SPECIFIED) THE PATIENT'S MOTHER ADMINISTERED FOOD AND DRINK. THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CSR GUIDED THE PATIENT THROUGH CHANGING THE CODE AND THE ALLEGED ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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. 3105187

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R