BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3133652 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13172
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    GENDER: NOT PROVIDED. WEIGHT: NOT PROVIDED. DATE OF EVENT: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. THE PATIENT REPORTED THAT ON AN UNSPECIFIED DATE ¿THREE MONTHS AGO¿ THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT NOTED SHE TOOK 60 UNITS AND THEN 40 UNITS INSULIN BASED ON HER SLIDING SCALE; THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. NO TROUBLESHOOTING WAS PERFORMED DURING THE CALL, AS THE PATIENT HAD DISCARDED THE METER. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT SUFFERED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER POWER ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234168 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR