BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3020507 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06255
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 8, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K1106937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT #1: ((B)(4) 2013) ADDITIONAL INFORMATION: THE PATIENT CONTACTED THE MSS ON (B)(4) 2013 AT 3:15PM IN RESPONSE TO A NO RESPONSE LETTER NOTIFICATION. THE PATIENT CONFIRMED ON (B)(4) 2013 AFTER THE ALLEGED ISSUE OCCURRED, HE SELF ADMINISTERED 4-5 CARBOHYDRATES TO INCREASE HIS BLOOD GLUCOSE. THE PATIENT REPORTED HAVING SYMPTOMS OF "FRUSTRATED AND CONFUSED" WHICH HE CORRELATED WITH LOW BLOOD GLUCOSE. THE PATIENT REPORTED LATER THAT EVENING HIS WIFE COULD NOT WAKE HIM UP, AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED. THE PATIENT REPORTED EMS ADMINISTERED GLUCOSE (TYPE UNKNOWN) AND HE WAS NOT TRANSPORTED TO THE HOSPITAL. THE PATIENT REPORTED THE FOLLOWING DAY, HE TESTED AGAIN ON THE LFS METER AND OBTAINED A "70MG/DL" AND COMPARED WITH AN ACCU-CHEK AND SHOWED "30MG/DL" WHICH HE BELIEVED TO BE ACCURATE. THE PATIENT REPORTED SINCE HE DID NOT TRUST THE LFS METER, HE DISCONTINUED USING IT. THE PATIENT REPORTED HE NORMALLY TESTS 6 TIMES A DAY, AND HIS TYPICAL READINGS ARE "70-120MG/DL." THE PATIENT REPORTED HE USES HUMALOG, 1 UNIT PER 12 UNITS AND LANTUS 26 UNITS A DAY TO MANAGE HIS DIABETES. THIS COMPLAINT IS REMAINING AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    (03/25/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE ALLEGED COMPLAINT 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)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAVERIOIQ METER WAS DISPLAYING AN INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS OR NORMAL RESULTS AS WELL AS ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013 AT 5PM HE OBTAINED READINGS OF "70MG/DL" COMPARED TO ANOTHER ACCU-CHEK METER WITH A READING OF "30MG/DL" AS WELL AS HIS FEELINGS OR NORMAL RESULTS. THE PATIENT REPORTED USING NO DIABETES MEDICATIONS TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 AT 8:20PM HE HAD LESS TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED 1 DAY LATER, HE DEVELOPED SYMPTOMS OF "DIABETIC COMA." THE PATIENT REPORTED ON (B)(6) 2013 AT 6:30AM. HE WAS GIVEN SOMETHING TO DRINK OR EAT BY A NON HEALTHCARE PROFESSIONAL THIRD PARTY. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS RUN AND THE RESULTS WERE WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PRODUCTS WERE REQUESTED FOR RETURN. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A THIRD PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123852 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302196

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R