BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3230765 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-19999
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 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
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIO IQ METER DISPLAYED AN ¿ERROR 2¿ MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 3X DAILY. THE PATIENT MANAGES HIS DIABETES WITH NOVOLIN INSULIN AND NPH INSULIN. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 12PM. THE PATIENT DID NOT TAKE HIS USUAL DOSE OF MEDICATIONS DUE TO NOT BEING ABLE TO TEST. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, THAT SAME AFTERNOON, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER). THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿599 MG/DL¿ WITH THE ER/ HOSPITAL METER. THE PATIENT WAS ADMINISTERED NOVOLIN INSULIN (10 UNITS) AS TREATMENT. ABOUT 10 MINUTES AFTER, THE PATIENT RETESTED AND REPORTEDLY OBTAINED A RESULT OF ¿AROUND 200 MG/DL¿ WITH THE ER/ HOSPITAL METER. THERE WAS NO INDICATION OF MISUSE. THE CCA WALKED THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332361 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3398907

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R