BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3160940 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16379
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 SHE WAS UNABLE TO TEST BECAUSE HER ONETOUCH VERIO IQ METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING ¿MID APRIL 2013.¿ THE PATIENT REPORTED USING SELF ADJUSTING INSULIN (HUMALOG) TO MANAGE HER DIABETES. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. HOWEVER THE PATIENT REPORTED ON A UNKNOWN DATE AND TIME, THE PATIENT WAS TREATED IN THE EMERGENCY ROOM (ER). THE PATIENT REPORTED A READING OF ¿300¿S MG/DL¿ WAS OBTAINED ON AN UNKNOWN METER AND THE PATIENT WAS TREATED WITH AN INCREASED DOSE OF INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE PATIENT WAS UNABLE TO CHARGE THE SUBJECT METE SINCE IT HAD BEEN PREVIOUSLY DISPOSED OF. WHEN THE CCA EDUCATED THE PATIENT ON THE AUTO SHUT OFF FUNCTION, THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST AND THEREFORE REQUIRED AN INTERVENTION FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263183 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R