BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6029243 · Received October 14, 2016

    Report

    Report Number
    3008382007-2016-52992
    Event Type
    Injury
    Date Received
    October 14, 2016
    Report Date
    September 26, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH IN COMPARISON TO RESULTS OBTAINED ON ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ¿ONE WEEK¿ PRIOR TO CONTACTING LFS SHE OBTAINED A RESULT OF ¿230MG/DL¿ ON THE SUBJECT METER, WHICH SHE FELT WAS INACCURATELY HIGH IN COMPARISON TO A RESULT OF ¿180MG/DL¿ OBTAINED ON ANOTHER DEVICE. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING HER INSULIN DOSES AND STATED THAT ¿ONE WEEK¿ PRIOR TO CONTACTING LFS SHE VISITED HER DOCTOR¿S OFFICE WHERE SHE HAD THE DOSE OF HER MEDICATION INCREASED FROM ¿10MG INSULIN IN THE MORNING AND 20MG INSULIN AT NIGHT TO 20MG INSULIN IN THE MORNING AND 30 MG AT NIGHT¿. THE PATIENT REPORTED THAT ¿ONE WEEK¿ PRIOR TO CONTACTING LFS, AFTER THE ISSUE HAD OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿DIZZY, SHAKING AND COLD SWEATS¿. THE PATIENT REPORTED THAT SHE HAD HER BLOOD GLUCOSE TESTED ON AN EMERGENCY ROOM METER WHICH GAVE RESULTS OF ¿170, 106 AND 110MG/DL¿. DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS USED. THE PATIENT HAD NOT FOLLOWED THE CORRECT TESTING PROCEDURE AS THE METER WAS SET TO THE WRONG CODE. PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT DEVELOPED SYMPTOMS THAT MEET LFS CRITERIA OF A SERIOUS HYPOGLYCEMIC EVENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682538 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4008721

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening