BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3181438 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17940
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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) (B)(4), ALLEGING HER ONETOUCH VERIO IQ METER WAS REVERTING TO THE SET UP MODE WHEN SHE WAS TRYING TO TEST. 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 ¿SWEATING AND CRAMPING.¿ IT IS UNCLEAR IF THE PATIENT ASSOCIATES THE SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE. THE PATIENT REPORTED GIVING HERSELF 15 UNITS OF HUMALOG, ATTEMPTED TO RETEST, AND THE ALLEGED ISSUE OCCURRED, SO SHE GAVE HERSELF ANOTHER 15 UNITS. THE PATIENT REPORTED SHE TRIED TESTING AGAIN AND OBTAINED A READING OF ¿22.XMMOL/L¿. THE PATIENT DID NOT REPORT DEVELOPING ANY ADDITIONAL SYMPTOMS DUE TO THE INCREASE IN MEDICATION. THE PATIENT DENIED USING ANOTHER DEVICE TO TEST HER BLOOD SUGAR. 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. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283293 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