BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2962467 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-03021
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (4/5/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 7 AM. HE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE TO "128 MG/DL" AND RETESTED AND WITH A DIFFERENT VIAL OF TEST STRIPS ON THE SAME DEVICE AND OBSERVED A VALUE OF "106 MG/DL" PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN THE EXPECTED VALUE OF (B)(4). THE PATIENT STATED HIS NORMAL BLOOD GLUCOSE VALUES ARE BETWEEN "75-85 MG/DL" (FASTING). THE PATIENT INFORMED THE MSS THAT HE MANAGES HIS DIABETES WITH NOVOLOG INSULIN AT MEAL TIMES BASED ON HIS CARBOHYDRATES AND LANTUS INSULIN AT BEDTIME. HE STATED 2 DAYS LATER BEFORE LUNCH HE TESTED ON THE SUBJECT METER AND OBSERVED ANOTHER HIGHER THAN NORMAL VALUE OF ">100 MG/DL" THE PATIENT COULDN'T RECALL THE EXACT READING. HE STATED HE TOOK 5 UNITS OF NOVOLOG INSULIN TO CORRECT FOR HIS MEAL AT APPROXIMATELY 1 PM AND SHORTLY THEREAFTER HE BECAME "DIZZY, HYPOGLYCEMIC, SWEATY AND COLD". HE IMMEDIATELY ATE HIS LUNCH IN ADDITION TO A GLUCOSE TABLET AND BEGAN TO FEEL BETTER WITHIN 30 MINUTES AFTER SELF TREATMENT. THE PATIENT ADVISED THE MSS DURING THE FOLLOW UP CALL THAT HE FEELS HIS LANTUS INSULIN MAY NOT HAVE BEEN EFFECTIVE BECAUSE HIS BLOOD GLUCOSE HAS SINCE STABILIZED SINCE HE SWITCHED TO A NEW BOTTLE OF LANTUS. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIPS WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66025 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302895

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening