BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3230913 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20141
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 10, 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
    NJ, 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) ALLEGING HER ONETOUCH VERIOIQ METER WAS PROMPTING AN ¿ERROR 4¿ MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT VERIOIQ OWNER¿S MANUAL, AN ERROR 4 INDICATES THAT (1) THERE WAS NOT ENOUGH BLOOD OR CONTROL SOLUTION WAS APPLIED OR MORE WAS ADDED AFTER THE METER BEGAN TO COUNT DOWN (2) THE TEST STRIP MAY HAVE BEEN DAMAGED OR MOVED DURING TESTING (3) THE SAMPLE WAS IMPROPERLY APPLIED (4) THERE MAY BE A PROBLEM WITH THE METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ¿A FEW MONTHS¿ PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 2 MONTHS PRIOR TO CONTACTING LFS SHE DEVELOPED SYMPTOMS OF ¿TREMBLING, HEADACHE AND EXTREME THIRST.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THE CCA NOTED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION. THE TEST STRIP REPORTEDLY COMPLETELY DREW IN THE SAMPLE. HOWEVER THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE WITH A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330724 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3333529

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening