BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3230751 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20002
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 5, 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
    MD, 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 REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT HER ONETOUCH ULTRALINK METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "50 AND 400 MG/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 LESS THAN OR EQUAL TO 20% AND/OR 20 MG/DL. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, STATED SHE CALLED EMERGENCY SERVICES BECAUSE SHE WAS CONCERNED ABOUT THE "400 MG/DL" RESULT SHE HAD OBTAINED. THE PATIENT STATED WHEN EMS ARRIVED THEY TESTED HER BLOOD GLUCOSE WITH THEIR METER AND OBTAINED A READING OF "240 MG/DL".THE REPORTER CONFIRMED SHE DID NOT RECEIVE ANY MEDICAL TREATMENT AND ALL EMS DID WAS CHECK HER BLOOD GLUCOSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331766 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3364880

    Patients

    Seq Age Sex Outcome Treatment
    1