BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4183433 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27950
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    October 16, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS DISPLAYING THE BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE BATTERY INDICATOR BEGAN TO APPEAR ON AN UNSPECIFIED DATE AND TIME PRIOR TO CONTACTING LFS AND THAT HE HAS TO CHARGE THE METER EVERY TIME HE GOES TO USE IT. THE PATIENT STATED, HE MANAGES HIS DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTED TAKING HIS USUAL DOSE OF MEDICATIONS (INCLUDING SLIDING SCALE). THE PATIENT STATED THAT DUE TO THE PRODUCT ISSUE HE HAD NOT BEEN TESTING HIS BLOOD GLUCOSE AS MUCH AND THEREFORE CLAIMED HE DEVELOPED SYMPTOMS OF ¿HIGHER BLOOD SUGAR¿, BUT DENIED RECEIVING ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THERE WAS NO MISUSE OF THE DEVICE AND IDENTIFIED THAT THE BATTERY DID NOT REQUIRE TO BE RECHARGED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE BATTERY INDICATOR ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING BATTERY INDICATOR. 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
    663927 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3653532

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR