BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2780952 · Received October 10, 2012

    Report

    Report Number
    2939301-2012-11793
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 17, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGED HIS SON'S ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO HIS SCHOOL'S OT ULTRALINK METER AND AN UNKNOWN ONETOUCH METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012, SEVERAL HOURS PRIOR TO THE START OF THE ALLEGED ISSUE, THE REPORTER ALLEGED HIS SON "DIDN'T FEEL GOOD." IT IS UNCLEAR IF THE PATIENT ATTRIBUTES THESE SYMPTOMS OR HIGH OR LOW BLOOD GLUCOSE. ON (B)(6) 2012, AT 11AM, THE REPORTER ALLEGED THE PATIENT TESTED ON HIS LFS METER AND OBTAINED A READING OF "298MG/DL" WHICH HE COMPARED WITH THE SCHOOL'S METER OF "198MG/DL." BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30MG/DL OR <=30% WHEN TAKEN WITHIN 30 MINUTES OF EACH OTHER. THE REPORTER ALSO COMPARED THE "298MG/DL" READING TO AN UNKNOWN READING ON A FRIEND'S UNKNOWN ONETOUCH METER. THE REPORTER STATED THE PATIENT USES INSULIN PUMP THERAPY (TYPE UNKNOWN) TO MANAGE HIS DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER DENIED IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION IN RESPONSE TO HIS SYMPTOMS. DURING THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE CCA NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR COLLECTION OF THE BLOOD SAMPLES. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL. BASED ON THE INFORMATION PROVIDED, THE SUBJECT METER DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTING THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT PERFORMED A METER VS. ANOTHER METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS MEETS LFS' CRITERIA FOR ACCURACY REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3306969

    Patients

    Seq Age Sex Outcome Treatment
    1