BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3181428 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17930
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING HIS ONETOUCH VERIO IQ METER WAS DISPLAYING A BATTERY INDICATOR EVERY 3-4 DAYS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE ALLEGED ISSUE HAD BEEN RECURRING SINCE THE FIRST USE OF THE METER, APPROXIMATELY 3 MONTHS PRIOR TO CONTACTING LFS. HOWEVER WHILE THE PATIENT WAS IN THE USA, THE ALLEGED ISSUE OCCURRED AND THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE. THE PATIENT REPORTED USING A COMBINATION OF JANUMET, 50/1000 TWICE A DAY AND DIAMICRON 30MG ONCE A DAY. AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CONTINUED TO TAKE HIS USUAL MEDICATIONS. THE PATIENT REPORTED 2 DAYS AFTER THE ALLEGED ISSUE OCCURRED HE FELT ¿LIGHT HEADED.¿ THE PATIENT REPORTED HE DECREASED HIS DIAMICRON TO 15 MG SINCE HE WAS FEELING LOW BLOOD GLUCOSE. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISUSE OF THE PRODUCT, AND THIS WAS NOT THE FIRST TIME THE METER HAS BEEN USED. THE METER¿S BATTERY DID NOT NEED TO BE RECHARGED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281700 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR