BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2421455 · Received January 19, 2012

    Report

    Report Number
    2939301-2012-00725
    Event Type
    Injury
    Date Received
    January 19, 2012
    Report Date
    January 9, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS DISPLAYING THE "BATTERY INDICATOR". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE OCCURRED AT AN UNSPECIFIED DATE AND TIME IN (B)(6) 2011. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH THE INSULIN PUMP AND DENIED MAKING ANY CHANGES TO HIS NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. AT AN UNKNOWN DATE AND TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "EXTREME THIRST AND DRY MOUTH" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE BATTERIES HAD BEEN REPLACED SEVERAL TIMES, BUT THE REPORTED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening