BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2513656 · Received April 2, 2012

    Report

    Report Number
    2939301-2012-03173
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Report Date
    March 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS READING ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT APPROXIMATELY 6:19PM. HE REPORTED HE OBSERVED BLOOD GLUCOSE RESULTS OF ''203, 142, 212, 117, 222, 146 AND 160MG/DL'' WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH AN UNKNOWN TYPE AND DOSE OF INSULIN THROUGH PUMP THERAPY AND REPORTEDLY INCREASED HIS INSULIN DOSE UP TO 35 UNITS FOR THAT DAY IN RESPONSE TO THE ALLEGED ISSUE. HE CLAIMED THAT APPROXIMATELY 2 HOURS AFTER TESTING, HE DEVELOPED SYMPTOMS OF ''A HEADACHE'' BUT DENIED RECEIVING ANY OTHER FORM OF TREATMENT OTHER THAN ADMINISTERING INSULIN. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT, AND THE RESULTS OBTAINED WERE FROM THE SAME APPROVED SAMPLE SITE AND THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A QUALITY CONTROL SOLUTION TEST WAS NOT PERFORMED SINCE THE PATIENT DID NOT HAVE THE SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS' DEFINITION SUGGESTIVE OF A SERIOUS INJURY NOR DID HE ADMINISTER INAPPROPRIATE SELF TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3229945

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR