BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3090964 · Received May 2, 2013

    Report

    Report Number
    3008382007-2013-10058
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 5, 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
    TX, US
    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) FOLLOWING RECEIPT OF THE ONETOUCH VERIOIQ VOLUNTARY RECALL LETTER. AT THE TIME OF THE CALL, THE PATIENT REPORTED THAT ONE OF HER THREE ONETOUCH VERIOIQ METER'S HAD POWERED OFF DURING. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED POWER ISSUE (UNIT POWERING OFF DURING USE) OCCURRED. THE PATIENT ALSO DID NOT KNOW WHICH OF HER THREE METERS SHE EXPERIENCED THE POWER ISSUE WITH. IT IS ALSO NOT KNOWN IF THE PATIENT WAS ABLE TO TEST WITH THE METER AFTER IT HAD POWERED OFF OR IF SHE TESTED WITH ANY OF HER OTHER METERS. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED POWER ISSUE. THE PATIENT INFORMED THE CCA THAT SHE DEVELOPED SYMPTOMS OF "LOW BLOOD SUGAR" 5-10 MINUTES AFTER THE ALLEGED POWER ISSUE OCCURRED. THE PATIENT STATED SHE WENT TO THE ER DUE TO THE LOW BLOOD GLUCOSE EXCURSION AND WAS TREATED WITH FOOD AND/OR DRINK. THE PATIENT ALSO REPORTED BEING TREATED WITH IV FLUID. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE REGISTERED WITH AN ER/HOSPITAL METER AT THE TIME OF HER ARRIVAL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT WAS REPORTEDLY TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191231 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R