BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3130778 · Received May 24, 2013

    Report

    Report Number
    3008382007-2013-13015
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 17, 2013
    Report Date
    May 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/REPORTER IN (B)(6), THE PATIENT¿S FATHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE REPORTER TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE REPORTER REFUSED TO TALK WITH THE TSR. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 200 MG/DL ON THE REPORTED METER, WHICH SHE CLAIMED WAS INACCURATELY HIGH. BASED ON THAT READING THE PATIENT TOOK INSULIN, TYPE AND DOSE NOT PROVIDED. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF CONVULSIONS. EMERGENCY SERVICES WERE CONTACTED, AND PARAMEDICS TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH INTRAVENOUS TREATMENT; THE SPECIFIC TREATMENT WAS NOT PROVIDED. WHILE IN THE HOSPITAL, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 220 MG/DL ON THE REPORTED METER, AND A READING ON A HOSPITAL METER THAT WAS ¿40 TO 50 MG/DL DIFFERENT¿; THE SPECIFIC RESULT WAS NOT PROVIDED. THE PATIENT MANAGED HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT¿S EXPECTED READINGS, HER INSULIN REGIMEN, WHAT DOSE INSULIN WAS TAKEN, HER BLOOD GLUCOSE READING WHILE SYMPTOMATIC, HER BLOOD GLUCOSE READING IN THE EMERGENCY ROOM, HER TREATMENT, AND THE METER READINGS OBTAINED PRIOR TO THE ONSET OF SYMPTOMS. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. THE PATIENT¿S FATHER REFUSED TO HAVE THE METER REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231080 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening| R