BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3120204 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12140
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 29, 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) (B)(4), ALLEGING SHE WAS UNABLE TO CHARGE HER ONETOUCH VERIOIQ METER. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED AT AN UNKNOWN TIME PRIOR TO THE START OF THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS OF BEING "TIRED AND SHAKY." THE PATIENT REPORTED THE ALLEGED ISSUE OCCURRED 1 MONTH PRIOR TO CONTACTING LFS. THE PATIENT REPORTED SINCE THE ALLEGED ISSUE OCCURRED, SHE HAS NOT USED THE METER AGAIN, AND SHE HAS BEEN USING A ONETOUCH ULTRAMINI METER INSTEAD. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THERE WAS NO MISUSE OF THE SUBJECT METER AND IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED. WHEN THE PATIENT PRESSED AND HELD THE POWER BUTTON, THE METER DID NOT TURN ON. WHEN A TEST STRIP WAS INSERTED THE METER DID NOT TURN ON. THE PATIENT WAS NOT ABLE TO FIND HER POWER CORD, THEREFORE WAS UNABLE TO ATTEMPT A CHARGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT REPORTED DEVELOPING SYMPTOMS PRIOR TO THE START OF THE ALLEGED ISSUE AND THERE WAS NO DELAY IN TREATMENT. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221524 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3370439

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR