BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3242109 · Received July 23, 2013

    Report

    Report Number
    3008382007-2013-20706
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENTS ONE TOUCH ULTRALINK METER WOULD POWER OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED POWER ISSUE BEGAN ON 07/13/2013 AT AN UNSPECIFIED TIME. IT IS NOT KNOWN WHAT MEDICATIONS, IF ANY, THE PATIENT TAKES TO MANAGE HIS DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED, AT AN UNSPECIFIED TIME BEFORE THE ALLEGED ISSUE OCCURRED, THE PATIENT BEGAN TO FEEL ¿VERY TIRED¿. THE REPORTER STATED THAT THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE SUBJECT METER, AND THERE WAS NO MISUSE OF THE PRODUCT. THE CCA NOTED THAT THE BATTERIES IN THE SUBJECT METER DID NOT NEED TO BE REPLACED. NO REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343931 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3468028

    Patients

    Seq Age Sex Outcome Treatment
    1