BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 4738854 · Received April 30, 2015

    Report

    Report Number
    2939301-2015-17343
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    April 24, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT ON AN UNKNOWN DATE/TIME, THEY OBTAINED A RESULT OF "153 MG/DL" USING THE SUBJECT METER COMPARED TO THE EXPECTED CONTROL SOLUTION RANGE "102-138 MG/DL". THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTING INSULIN. THE PATIENT STATED THAT THEY TOOK THEIR USUAL DOSE OF SLIDING SCALE MEDICATION IN RESPONSE TO THE ALLEGED INACCURACY. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOMS OF "SHAKY AND DEPRESSION" AT AN UNKNOWN DATE/TIME AFTER THE ALLEGED INACCURACY BEGAN; HOWEVER THE PATIENT DENIED HAVING RECEIVED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE CONTROL SOLUTION HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE TEST STRIPS HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN, THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A WALK THROUGH TEST, THE TEST STRIPS WERE NOT IDENTIFIED AS COUNTERFEIT/SUSPECT, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING AND THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "SHAKY" AFTER THE ALLEGED INACCURACY BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284195 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3763696

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening