BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2792628 · Received October 16, 2012

    Report

    Report Number
    3008382007-2012-05081
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 21, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO ERROR MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTS AND THE POWER BUTTON IS FUNCTIONING NORMALLY. THE ALLEGED 'ERROR 1' IS NOT REPRODUCED. THE TEST STRIPS WERE ALSO RETURNED. HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER ISSUE ONLY. 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) 2012, THE LAY USER/PATIENT'S WIFE (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT HER HUSBAND'S ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 1 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012 (TIME NOT SPECIFIED). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER) AND ACCORDING TO THE REPORTER, THE PATIENT CONTINUED WITH HIS USUAL DOSE OF 28 UNITS OF INSULIN PLUS HORMONE SHOT AND 25 UNITS IN THE AFTERNOON. THE REPORTER DENIED THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, ACCORDING TO THE REPORTER THE PATIENT WENT TO THE EMERGENCY ROOM (ER) LATER THAT AFTERNOON, HIS BLOOD GLUCOSE WAS TESTED WITH THE ER'S METER (RESULT NOT KNOWN), AND HE WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL (HCP) A GLUCAGON INJECTION AS TREATMENT. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3233862

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention