BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2931703 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01667
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH AS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 11:20AM. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH METFORMIN PILLS 500MG, 1 IN THE MORNING AND 1 AT NIGHT, ONGLYZA 5MG, 1 IN THE MORNING AND GLUCONORM (5MG) IN THE MORNING. A COUPLE OF MINUTES BEFORE TESTING ON THE SUBJECT DEVICE, HE CLAIMED HE WAS EXPERIENCING SYMPTOMS OF "SWEATING, SHAKING AND CONFUSION." THE PATIENT STATED HE TESTED WITH THE SUBJECT METER AND OBSERVED A VALUE OF "6.2 MMOL/L," WHICH HE DIDN'T FEEL WAS CORRECT. APPROXIMATELY 15 MINUTES LATER, HE TESTED ON ANOTHER METER (ACCUCHEK) AND OBSERVED A VALUE OF "4.2 MMOL/L." THE PATIENT REPORTEDLY SELF-TREATED HIS SYMPTOMS WITH ORANGE JUICE AND HIS DINNER (PASTA) AND FELT BETTER WITHIN 15 MINUTES OF EATING. THE PATIENT REPORTED THAT PRIOR TO OBTAINING THE ALLEGED INACCURATE RESULT; HE TESTED AT 8:30AM, WITH THE SUBJECT DEVICE AND OBSERVED A VALUE OF "11.5 MMOL/L." THE PATIENT CONSIDERS HIS NORMAL BLOOD GLUCOSE VALUES TO BE IN THE RANGE OF "7.0 - 10.0 MMOL/L." HE DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THIS READING. HE HAD LAST TAKEN HIS USUAL DIABETES MEDICATIONS AT 6:30AM THAT MORNING AFTER BREAKFAST. THE PATIENT REPORTED SINCE HE CONTACTED LFS FOR ASSISTANCE ON (B)(6) 2013, HE WENT TO SEE HIS DOCTOR PER THE DOCTOR'S ADVICE HE HAS DISCONTINUED TAKING THE GLUCONORM PILLS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT DEVICE DID NOT MEET LFS'S CRITERIA FOR ACCURACY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37217 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3380346

    Patients

    Seq Age Sex Outcome Treatment
    1