BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3233897 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20277
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 25, 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
    NJ, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY LOW WHEN COMPARED AGAINST ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2013. AT AN UNSPECIFIED TIME, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF ¿300 MG/DL¿ WITH THE SUBJECT METER AND ¿700 MG/DL¿ WITH ANOTHER (UNSPECIFIED) METER, PERFORMED MORE THAN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). THAT MORNING (ON (B)(6)), THE PATIENT REPORTEDLY WAS NOT FEELING WELL; IT IS NOT KNOWN HOWEVER, IF PATIENT WAS SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE AND HER SYMPTOM(S) IS NOT SPECIFIED. ACCORDING TO THE CSR¿S DOCUMENTATION, IN RESPONSE TO THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY CONSUMED LESS FOOD/DRINK THAT MORNING AND LATER (EITHER IN THE AFTERNOON OR EVENING) THAT DAY THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) WHERE SHE WAS ADMINISTERED IV FLUIDS AS TREATMENT. PRIOR TO GOING TO THE ER, IT IS NOT KNOWN WHAT HER BLOOD GLUCOSE READING WAS WITH THE SUBJECT METER AND IT IS NOT CLEAR IF THE PATIENT ATTEMPTED TO TREAT HERSELF. DURING THE PATIENT¿S TIME IN THE ER, IT IS NOT KNOWN IF SHE RECEIVED ANY ADDITIONAL TREATMENT, IT IS NOT CLEAR WHEN HER SYMPTOMS IMPROVED, AND THE EXTENT OF HER ER VISIT IS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335772 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3397773

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening