BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3070511 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08546
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 4 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY WITHIN THE 2 WEEKS PRIOR TO CALLING LFS. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH 30/70 HUMULIN INSULIN. SHE CLAIMED THAT 3-4 NIGHTS DURING THAT SAME WEEK OF (B)(6), SHE DEVELOPED SYMPTOMS OF ¿SWEATING AND SHAKING WHICH SHE ASSOCIATED WITH HYPERGLYCEMIA, THE PATIENT REPORTEDLY INCREASED HER DOSE OF INSULIN FROM 26 UNITS TO 28 UNITS AS A RESULT OF THE ISSUE. NO OTHER FORM OF TREATMENT WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE TEST STRIPS WERE IN GOOD CONDITION AND SHE CONFIRMED THE SAMPLE DID DRAW INTO THE TEST STRIP COMPLETELY HOWEVER, THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172541 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3365797

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening