BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2051858 · Received April 12, 2011

    Report

    Report Number
    2939301-2011-03049
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS NOT POWERING ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 BETWEEN 8:00AM AND 9:30AM. THE PATIENT CLAIMED SHE IS ON AN INSULIN PUMP TO MANAGE HER DIABETES. DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED SHE CONTINUED ADMINISTERING AN UNSPECIFIED TYPE/DOSE OF INSULIN. THE PATIENT REPORTED FEELING DIZZY, NAUSEAS, AND WAS INCOHERENT 5 HOURS AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE CCA DOCUMENTATION, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) AROUND THE SAME TIME THE ALLEGED ISSUE BEGAN; HOWEVER IT IS NOT KNOWN WHAT TYPE OF TREATMENT, IF ANY, THE PATIENT RECEIVED AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NOT MISUSED, THE CORRECT TEST STRIPS WERE USED, AND THE METER REQUIRED NO BATTERY REPLACEMENT. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID SHE RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3093948

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR