BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3901137 · Received June 30, 2014

    Report

    Report Number
    2939301-2014-15704
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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) 2014, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) USA ON BEHALF OF THE PATIENT, ALLEGING THAT THE ONETOUCH VERIO IQ METER IS PROMPTING THE PATIENT TO INSERT A NEW TEST STRIP. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT DUE TO THE MESSAGE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "NUMBNESS AND BLURRY VISION." THE REPORTER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION ABOUT THE ALLEGED ISSUE. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE INFORMATION SURROUNDING THE PATIENT¿S REPORTED SYMPTOMS; HOWEVER, THE PATIENT WAS NOT AVAILABLE FOR FOLLOW-UP INFORMATION. DURING TROUBLESHOOTING, THE PATIENT DID NOT HAVE ANY TESTING SUPPLY. HENCE, THE ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA DUE TO THE ALLEGED PRODUCT ISSUE. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379909 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3375462

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening