BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3141359 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14106
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 8, 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
    NY, 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 VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿130 MG/DL¿ WITH THE SUBJECT METER AND ¿116 MG/DL¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, ON (B)(6) 2013, PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT WENT TO HER PHYSICIAN¿S OFFICE AND WAS ADVISED TO DECREASE HER USUAL DOSE OF ORAL MEDICATIONS (AMOUNT NOT SPECIFIED). AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SWEATING AND HAD A ¿DRAINING¿ FEELING. THE PATIENT REPORTEDLY TOOK MORE FOOD AND/ OR DRINK. THE PATIENT DENIED TESTING WITH ANOTHER METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244229 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3398908

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R