BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3972556 · Received August 1, 2014

    Report

    Report Number
    2939301-2014-19340
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 30, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING HER ONETOUCH VERIO IQ METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT AN UNKNOWN TIME IN THE EVENING. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH NOVOMIX 30 INSULIN AND SHE REPORTED SKIPPING HER EVENING DOSE AT 10PM IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. SHE REPORTED TESTING ON ANOTHER METER AT APPROXIMATELY 10PM THAT NIGHT AND REPORTED OBTAINING A VALUE OF ¿11.4 MMOL/L.¿ AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER POWERED ON WITH THE TEST STRIPS BUT NOT WITH THE POWER BUTTON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS¿S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING POWER BUTTON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449556 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR