BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2042752 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02880
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 HER ONETOUCH ULTRALINK METER DISPLAYED AN "ER 5" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 430PM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN. THE PATIENT STATED SHE TOOK HER USUAL DOSE OF HUMALOG INSULIN (AMOUNT NOT CLEAR). ABOUT 5-10 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE HAD A HEADACHE, FELT "MENTALLY DULL," HOT AND DID NOT FEEL GOOD. THE PATIENT CONFIRMED SHE WAS ABLE TO OBTAIN A BLOOD GLUCOSE RESULT OF "261 MG/DL" ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA TRIED TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED "ER 5" MESSAGE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3070105

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR