BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2874969 · Received December 16, 2012

    Report

    Report Number
    3008382007-2012-08307
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 28, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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)(4) 2012 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING THE ONETOUCH VERIO IQ METER WAS DISPLAYING AN APPLY SAMPLE MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED IMMEDIATELY PRIOR TO THE ALLEGED ISSUE THE PATIENT HAD SYMPTOMS OF FEELING "SWEATY." THE REPORTER STATED THE ALLEGED ISSUE FIRST STARTED ON (B)(6) 2012 AT 7:15PM. THE REPORTER STATED THE PATIENT TAKES INSULIN AND ORAL MEDICATIONS (UNKNOWN TYPE AND DOSE) TO MANAGE HIS DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTED STATED THE PATIENT DID NOT RECEIVE ANY TREATMENT IN REGARDS TO HIS ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TESTING PROCESS, AND THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED ISSUE WAS NOT RESOLVED WITH A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER STATED THE PATIENT WAS SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE THE METER COULD NOT HAVE CAUSED THE INJURY. IN ADDITION THERE IS NO INDICATION THAT THE SUBJECT METER MALFUNCTIONED BASED ON THE TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302197

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR