BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3181440 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17941
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 11, 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

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH VERIO IQ METER NOT CHARGING. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING THE BEGINNING OF (B)(6) 2013. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING HUMALOG 3 TIMES A DAY, METFORMIN 3 TIMES A DAY, JANUVIA 3 TIMES A DAY AND LEVEMIR TWICE A DAY. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿VOMITING AND HEADACHE.¿ IT IS UNCLEAR IF THE PATIENT ASSOCIATES THE SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE. THE PATIENT REPORTED SHE TOOK AN UNKNOWN AMOUNT OF INSULIN BASED ON HER SYMPTOMS. THE PATIENT REPORTED GOING TO THE DOCTOR¿S OFFICE DURING THE BEGINNING OF (B)(6) 2013 AND ONLY A BLOOD GLUCOSE TEST WAS OBTAINED AND IT READ ¿23.9 MMOL/L.¿ THE PATIENT REPORTED THE DOCTOR ARRANGE FOR HER TO GET A REPLACEMENT METER. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND IT DID NOT OCCUR AFTER RECHARGING THE BATTERY. THERE WAS NO MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THERE WERE NO BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT REPORTED WHICH SUGGEST AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281703 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR