BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3972553 · Received August 1, 2014

    Report

    Report Number
    2939301-2014-19342
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 13, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE. THE PATIENT DID NOT RECALL WHEN THE METER INACCURACY ISSUE STARTED. HE INFORMED THE CUSTOMER CARE ADVOCATE (CCA) THAT HE WAS OBTAINING SEVERAL ELEVATED RESULTS IN THE ¿300¿S MG/DL¿ RANGE AND ONCE OBTAINED A HIGH RESULT IN THE ¿400¿S MG/DL.¿ THE PATIENT MENTIONED THAT HE TAKES INSULIN INJECTIONS TO MANAGE HIS DIABETES. IN RESPONSE TO THE ELEVATED READINGS HE WAS OBTAINING, THE PATIENT REPORTED HE WOULD ADJUST HIS INSULIN DOSAGE BASED ON THE METER RESULT. THE PATIENT MENTIONED TO THE CCA THAT ON AT LEAST ONE OCCASION AFTER HAVING TAKEN AN INSULIN INJECTION HE DEVELOPED A LOW BLOOD GLUCOSE. THE PATIENT MENTIONED HE WAS SWEATING AND AT TIME SYMPTOMS HIS BLOOD GLUCOSE MEASURED ¿47 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT REPORTED TREATING SELF WITH ORANGE JUICE. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449555 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3493247

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R