BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2930071 · Received January 25, 2013

    Report

    Report Number
    3008382007-2013-01477
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT'S SPOUSE CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, BETWEEN 9 AND 10PM. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH AN UNKNOWN TYPE AND DOSE OF INSULIN AND IS A SELF ADJUSTER. SHE STATED BECAUSE THE PATIENT WAS UNABLE TO CHECK HIS BLOOD GLUCOSE DUE TO THE ISSUE, HE SKIPPED HIS DOSE OF INSULIN BETWEEN 9 AND 10PM. AT AROUND THE SAME TIME AS THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "STOMACH CRAMPS, SHAKES, VERY TIRED, MOODY, HOT SWEATS, CHILLS, FREQUENT URINATION, DRY MOUTH, ACHING LEGS AND FEET." THE REPORTER STATED THE SYMPTOMS BECAME WORSE AFTER THE ISSUE OCCURRED. THE EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND WHEN THEY ARRIVED, THEY TESTED THE PATIENT USING AN EMS METER AND OBSERVED A RESULT OF "568MG/DL" SOMETIME BETWEEN 9-10PM. THE PATIENT WAS REPORTEDLY TREATED WITH IV FLUIDS AND IV INSULIN AT THE EMERGENCY ROOM FOR 4 HOURS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS, AND FOLLOWING THE CORRECT TESTING TECHNIQUE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT/REPORTER CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, DID NOT TAKE HIS INSULIN AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA THAT REQUIRED HCP TREATMENT AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35144 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3246694

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R