BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2962210 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-03018
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 21, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2013, THE LAY USER/REPORTER, THE PATIENT'S FATHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2013 THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE REPORTER TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2013 AT 6:30 PM, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF SHAKING AND FEELING VERY FAINT. THE PATIENT'S FATHER REPORTED THAT THIS OCCURRED AFTER INCREASED PHYSICAL ACTIVITY AND THE PATIENT'S PUMP BASAL RATE HAD NOT BEEN ADJUSTED. WHILE SYMPTOMATIC, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 100 MG/DL AND 75 MG/DL ON THE REPORTED METER, AND THE READINGS OF 35 MG/DL AND 25 MG/DL ON A BACKUP METER, WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION, AND FELT BETTER AFTERWARDS. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE REPORTER WAS UNABLE TO STATE WHAT THE PATIENT'S BLOOD GLUCOSE LEVELS HAD BEEN PRIOR TO THE ONSET OF SYMPTOMS. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT¿S SYMPTOMS OCCURRED PRIOR TO THE METER ISSUE, AND WERE RELATED TO INCREASED PHYSICAL ACTIVITY WITHOUT ADJUSTING THE PUMP BASAL RATE. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-METER ACCURACY TESTING, AND ALSO AS THE RESULTS DID NOT CORRELATE WITH THE PATIENT'S SYMPTOMS AND TREATMENT, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65980 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3359858

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR