BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3192982 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18619
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 3, 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
    NC, 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 VERIOIQ METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2013. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿150, 190 AND 150 MG/DL¿ WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20% . THE PATIENT MANAGES HER DIABETES WITH INSULIN (INSULIN PUMP THERAPY); HOWEVER, IT IS NOT KNOWN IF SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO AN ALLEGED INACCURATE READING OBTAINED WITH THE SUBJECT METER. THE PATIENT INFORMED THE CCA THAT A COUPLE OF HOURS AFTER OBTAINING AN INACCURATE RESULT SHE DEVELOPED SYMPTOMS OF SHAKY AND DIZZY; HOWEVER, DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT WAS USING THE CORRECT TECHNIQUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292549 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3445176

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR