BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3120679 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12147
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 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
    AZ, 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 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. ON (B)(6) 2013, AT 10:30 PM, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK THE ACTION OF TAKING HIS USUAL DOSE OF DIABETES MEDICATIONS. AT 10:30 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF FREQUENT URINATION AND ¿NOT FEELING WELL¿. THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING 3.0 UNITS NOVOLOG INSULIN; HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE CORRECT AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE METER POWER ISSUE, AND RECEIVED TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221428 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3307279

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening