BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3220567 · Received July 11, 2013

    Report

    Report Number
    3008382007-2013-19459
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS PROMPTING AN ERROR 5 MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT ULTRAMINI OWNER¿S MANUAL, AN ERROR 5 MESSAGE PROMPTS WHEN THERE IS A PROBLEM WITH THE TEST STRIP OR THE CONFIRMATION WINDOW HAS NOT BEEN COMPLETELY FILLED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED 1 WEEK PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS TO MANAGE HER DIABETES INCLUDING LEVEMIR 20 UNITS, UNKNOWN INSULIN 20 UNITS, ACTOS 45 MG, AND GLIPIZIDE 5 MG. THE PATIENT REPORTED ON (B)(6) 2013 AT NOON, SHE HAD HER USUAL DOSE OF MEDICATIONS. THE PATIENT REPORTED 3-4 DAYS AFTERWARDS SHE ¿PASSED OUT.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 6 PM, A READING OF ¿35 MG/DL¿ WAS OBTAINED AND SHE WAS TREATED BY EMERGENCY MEDICAL SERVICES (EMS) WITH IV FLUIDS. IT IS UNCLEAR IF THE IV FLUIDS CONTAINED GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE SUBJECT METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE SUBJECT METER. THE PATIENT WAS FOUND TO BE USING THE CORRECT TEST STRIPS. WHEN A NEW TEST STRIP WAS INSERTED, THE METER TURNED ON. THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH A RETEST. THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE SHE WAS UNABLE TO TEST THEREFORE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319564 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388026

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R