BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3183254 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17985
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 29, 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
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIO IQ METER WAS DISPLAYING A BATTERY INDICATOR WHEN ATTEMPTING TO TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATES (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. HE CLAIMED AT AN UNKNOWN TIME THAT SAME DAY HE DEVELOPED SYMPTOMS OF ¿SHAKING AND SLURRED SPEECH¿ BUT HE COULD NOT RECALL WHETHER THE SYMPTOMS OCCURRED BEFORE OR AFTER THE ISSUE OCCURRED. AT AN UNKNOWN TIME THAT DAY, HE REPORTED TESTING USING ANOTHER METER AND OBSERVED A VALUE OF ¿AROUND 215MG/DL¿ AND SELF TREATED WITH A JANUVIA PILL, 100MG AT AN UNKNOWN TIME. IT WOULD HAVE BEEN HELPFUL TO KNOW WHETHER THE PATIENT DEVELOPED THE SYMPTOMS BEFORE OR AFTER THE ALLEGED ISSUE OCCURRED AND WHETHER HE ASSOCIATED THE SYMPTOMS WITH LOW OR HIGH BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME; THE BATTERY DID NOT NEED CHARGING BASED ON THE USE OF METER. THE ISSUE REMAINED UNRESOLVED AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282866 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387097

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening