BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3101004 · Received May 8, 2013

    Report

    Report Number
    3008382007-2013-10730
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 24, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER WAS DISPLAYING INACCURATELY LOW AND HIGH READINGS COMPARED TO THE SAME METER AND COMPARED TO A DOCTOR'S METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT'S MOTHER ON (B)(6) 2013. THE REPORTER STATED THE ALLEGED ISSUE HAD BEEN RECURRING FOR SEVERAL WEEKS. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT AN UNKNOWN TIME. THE REPORTER STATED DURING (B)(6) 2013 THE ISSUE HAD BEEN RECURRING, THEREFORE SHE INSTRUCTED HER DAUGHTER TO TAKE BACK TO BACK READINGS ON THE SUBJECT METER AS WELL AS HER BACK UP ONETOUCH ULTRAMINI METER. THE REPORTER ALLEGED SHE OBTAINED READINGS OF "350, 337 MG/DL" ON THE VERIOIQ COMPARED TO "296 MG/DL" ON THE OT ULTRAMINI METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4), TAKEN WITHIN 10 MINUTES OF ONE ANOTHER. THE REPORTER STATED THE PATIENT USES INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE REPORTER STATED ON (B)(6) 2013 ((B)(6)), THE PATIENT "PASSED OUT" AFTER ADMINISTERING INSULIN DUE TO AN UNKNOWN HIGH READING, AND THE PATIENT WAS GIVEN FOOD IN HER CHEEK, AND WITHIN 5-10 MINUTES HER SYMPTOMS ABATED. THE REPORTER STATED ON (B)(6) 2013 ((B)(6)) SHE TOOK THE PATIENT TO THE DOCTOR'S OFFICE, AND HER LABS WERE DRAWN. THE REPORTER STATED HER LABS WERE "NORMAL", HER HGB A1C READING WAS 7%. THE REPORTER STATED A LAB READING OF "67 MG/DL" WAS OBTAINED WHILE AT THE DOCTOR'S OFFICE AND THE METER WAS READING "29 MG/DL".THE REPORTER STATED THE PATIENT WAS TAKEN BACK TO THE DOCTOR'S OFFICE ON (B)(6) 2013 ((B)(6)) SINCE THE ALLEGED ISSUE WAS STILL RECURRING. THE REPORTER STATED THE PATIENT WAS ALSO TRANSPORTED BY HER MOTHER TO THE EMERGENCY ROOM (ER) ON (B)(6) 2013 DUE TO HAVING SYMPTOMS OF LOW BLOOD GLUCOSE AGAIN, AND SHE WAS TREATED WITH ORANGE JUICE AND A SNACK. THE REPORTER WAS UNABLE TO RECALL ANY READINGS OBTAINED BY THE ER. THE REPORTER STATED SHE WAS NOT TREATED WITH IV GLUCOSE OR GLUCAGON INJECTION. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE CCA CONFIRMED THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR OBTAINING THE SAMPLE AND THE CORRECT TESTING STEPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED SINCE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUES, THE PATIENT WAS UNABLE TO PROPERLY MAINTAIN HER BLOOD GLUCOSE LEVELS, GAVE HERSELF TOO MUCH INSULIN, AND DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A THIRD PARTY AND A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200546 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R