BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3160942 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16382
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 23, 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
    FL, 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 HER ONETOUCH VERIOIQ METER WAS READING CONTROL SOLUTION INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013. THE PATIENT ALLEGED OBTAINING A CONTROL SOLUTION READING OF ¿90 MG/DL¿ ON THE LFS METER. THE PATIENT REPORTED TAKING A COMBINATION OF MEDICATIONS INCLUDING NOVOLOG AND LANTUS TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SWEATING AND NAUSEOUS¿ 30 MINUTES AFTER THE ALLEGED ISSUE OCCURRED. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION AND IT WAS IN GOOD CONDITION. THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT¿S TESTING PROCESS WAS CORRECT. THE CCA CONFIRMED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. HOWEVER WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST, THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262249 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR