BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3079289 · Received April 25, 2013

    Report

    Report Number
    3008382007-2013-09224
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    April 19, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/07/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON 5/21/2013 AND 5/20/2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY; PA WAS UNABLE TO REPRODUCE THE COMPLAINT. THE TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH VERIO IQ METER READ INACCURATELY. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT USUALLY TESTS HER BLOOD GLUCOSE 3X DAILY BUT HAS BEEN TESTING UP TO 6-7X DAILY SINCE THE START OF THE ALLEGED ISSUE. THE PATIENT MANAGES HER DIABETES WITH NOVORAPID INSULIN (6 UNITS) AND LANTUS INSULIN (8 UNITS). THE ALLEGED ISSUE BEGAN IN (B)(4) 2012. RESULTS OBTAINED AT THAT TIME WERE NOT SPECIFIED. IN (B)(6) 2012, THE PATIENT REPORTED RESULTS OF "250-390 MG/DL" WITH THE SUBJECT METER. THE PATIENT ALLEGED STARTING TO HAVE SYMPTOMS OF SWEATING, FATIGUE, HEADACHE AND EYESIGHT PROBLEMS WHICH CORRELATED WITH HER RESULTS. THE PATIENT DENIED RECEIVING TREATMENT. THAT SAME MONTH, THE PATIENT REPORTEDLY VISITED HER PHYSICIAN'S OFFICE AND WAS ADVISED TO INCREASE HER USUAL DOSE OF NOVORAPID INSULIN (TO 10 UNITS) AND LANTUS INSULIN (TO 12 UNITS). ABOUT 3 WEEKS PRIOR TO CONTACTING LFS, THE PATIENT ALSO REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF "578 MG/DL" WITH THE SUBJECT METER. THE PATIENT REPORTEDLY ADMINISTERED SELF LANTUS INSULIN (10 UNITS). LATER THAT SAME DAY, ABOUT 230 PM, THE PATIENT RETESTED WITH THE SUBJECT METER AND OBTAINED A RESULT OF "27 MG/DL". THE PATIENT CLAIMS SHE FELT SYMPTOMS OF PERSPIRATION, BAD VISION AND STOMACH PAIN. THE PATIENT ATE SUGAR AS TREATMENT AND FELT BETTER ABOUT 30 MINUTES LATER. THE PATIENT RETESTED AND OBTAINED A BLOOD GLUCOSE RESULT OF "80 MG/DL" WITH THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178145 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3421501

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R