BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2972282 · Received February 21, 2013

    Report

    Report Number
    3008382007-2013-03402
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IN (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 11.8 MMOL/L ON THE REPORTED METER AND A READING OF 7.3 MMOL/L ON ANOTHER METER WITHIN 30 MINUTES. AT THAT TIME, THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED SHE HAD TAKEN INCREASED DOSES OF HUMALOG INSULIN BASED ON METER READINGS FOR TWO WEEKS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT DID NOT SUFFER ANY SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76087 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3362692

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR