BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3031886 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06872
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 14, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    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. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT LUNCHTIME. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE) THROUGH PUMP THERAPY AND DENIED MAKING ANY CHANGES TO HER MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED THAT APPROXIMATELY 1 HOUR AFTER ATTEMPTING TO TEST WITH THE SUBJECT DEVICE, SHE BECAME "TIRED, DEVELOPED DRY MOUTH." SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS AND THE BATTERIES DID NOT NEED REPLACING, BUT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136230 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3311155

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening