BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4242154 · Received November 11, 2014

    Report

    Report Number
    2939301-2014-30208
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 27, 2014
    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
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/03/2015). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 1/15/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/21/2015 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR ADDITIONAL INFORMATION. THE PATIENT STATED THE ALLEGED ISSUE OCCURRED ON AN UNKNOWN DATE DURING ¿THE LAST 7 DAYS¿ PRIOR TO THE ALERT DATE OF (B)(6) 2014. THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READING OF "13.5MMOL/L" WITH THE SUBJECT METER, AND ¿3.6MMOL/L¿ ON ANOTHER DEVICE, PERFORMED LESS THAN 30 MINUTES BETWEEN EACH OTHER. IT IS NOT KNOWN WHAT FORM OF MEDICATION, IF ANY, THE PATIENT TAKES IN ORDER TO REGULATE THEIR DIABETES, AND IT IS NOT KNOWN IF THEY HAD MADE ANY CHANGES TO THEIR ROUTINE PRIOR TO THE ALLEGED INACCURACY. IT WAS NOTED THAT THE PATIENT EXPERIENCED ¿SHAKING¿, FEELING ¿LIGHT-HEADED¿ AND HAD A ¿RAPID HEART RATE¿ ¿RIGHT AWAY¿ BEFORE THE PRODUCT ISSUE BEGAN. THE CSR NOTED THAT NO TREATMENT WAS RECEIVED AS A RESULT OF THESE SYMPTOMS. IT IS NOT KNOWN IF THE PATIENT TESTED THEIR BLOOD GLUCOSE ON ANOTHER DEVICE DURING THIS PERIOD. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT THE CORRECT UNIT OF MEASURE WAS SET ON THE SUBJECT METER AND THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT EXPERIENCED THE SYMPTOMS OF ¿SHAKING¿ AND ¿RAPID HEART RATE¿ WHICH ARE SUGGESTIVE OF SEVERE INJURY, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED/CONTRIBUTED TO THIS SERIOUS INJURY BECAUSE THIS SYMPTOM WAS EXPERIENCED PRIOR TO THE PRODUCT ISSUE FIRST OCCURRING. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THIS CONDITION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725994 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3645279

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR