BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 867208 · Received June 13, 2007

    Report

    Report Number
    2939301-2007-00480
    Event Type
    Injury
    Date Received
    June 13, 2007
    Date of Event
    June 9, 2007
    Report Date
    June 11, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM THE FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JUNE 11, 2007, THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING THAT HIS ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE REPORTER ON JUNE 12, 2007 TO OBTAIN/CLARIFY INFORMATION. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS HAD BEEN IN THE RANGE OF 120-220 MG/DL, WHICH THEY CONSIDER NORMAL. IN 2007, AT APPROXIMATELY 2 PM, THE PATIENT GOT A READING OF 363 MG/DL AND TOOK 8 UNITS OF HUMALOG INSULIN. HE HAD EATEN BREAKFAST AT 10 AM AND LUNCH AT 1:00, ACCORDING TO HIS NORMAL SCHEDULE BEFORE TAKING THE HUMALOG. HE IS CURRENTLY TAKING NPH, HUMALOG, AND LANTUS FOR HIS DIABETES; THE SLIDING SCALE REGIMENS ARE UNKNOWN. THE PATIENT TESTS HIS BLOOD SUGAR 3-4 TIMES A DAY. AT 4 PM ON THE SAME DAY, TWO HOURS AFTER TAKING 8 UNITS OF HUMALOG, THE PATIENT STARTED EXPERIENCING SYMPTOMS OF HOT FLASHES THAT HE INTERPRETED AS FLU-LIKE ALTHOUGH HE HAS HAD THE SAME SYMPTOMS WHEN HE EXPERIENCES HYPOGLYCEMIA. HE TOOK A READING AT THAT POINT THAT READ 236 MG/DL WHICH HE THOUGHT WAS NORMAL AND LIED DOWN. ABOUT 1-1.5 HOURS LATER, THE PATIENT FELL UNCONSCIOUS AND HAD SEIZURES. THIS IS THE FIRST TIME HE HAS SEIZED. THE REPORTER GAVE HIM COMPRESSES BEFORE CALLING EMERGENCY SERVICES AT 7:30 PM. THEY ARRIVED 5 MINUTES AFTERWARD. THEY PROMPTLY TESTED HIS BLOOD SUGAR ON THEIR METER AND OBTAINED A READING OF 26 MG/DL. AT THE TIME THE SEIZURES STOPPED AND HE WAS GIVEN GLUCOSE INTRAVENOUSLY AND OXYGEN. AT AROUND 8 PM, THE PATIENT ARRIVED AT THE HOSPITAL AND BEGAN TO REGAIN CONSCIOUSNESS. THE REPORTER VAGUELY REMEMBERS READINGS IN THE 300 MG/DL RANGE AT THE HOSPITAL ALTHOUGH THE TIMES WERE NOT SPECIFIED HE WAS DISCHARGED AT 1:00 AM WITH A READING OF 176 MG/DL. THE PATIENT WAS KEPT IN THE EMERGENCY ROOM FOR OBSERVATION, WAS GIVEN BOLUS FLUIDS OF SUGAR INTERMITTENTLY, AND FOOD IN THE FORM OF PEANUT BUTTER AND CRACKERS. THE ONLY DIAGNOSIS AT THE HOSPITAL WAS THAT OF UNCONTROLLED BLOOD GLUCOSE. THE PATIENT HAS CONGENITAL HYPOPLASTIC ANEMIA AND REQUIRES BLOOD TRANSFUSIONS EVERY THREE WEEKS. THE LAST TIME HE HAD A BLOOD TRANSFUSION WAS ONE MONTH PRIOR. HIS DIABETES IS SECONDARY TO IRON OVERLOAD ON HIS PANCREAS FROM BLOOD TRANSFUSIONS. HE HAD A HEMATOCRIT LEVEL OF 29.2% AT THE TIME THE HOSPITAL VISIT THAT IS BELOW THE METER SPECIFICATIONS OF 30-55%. AFTER THE INCIDENT, HIS SLIDING SCALE INSULIN DOSAGES HAVE DECREASED AND HE TESTS EVERY 2 HOURS HE IS AWAKE. THE CUSTOMER CARE ADVOCATE (CCA) VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT AND THE PUNCTURE AREA WAS CLEANSED CORRECTLY. THE RESULTS WERE VERIFIED IN THE METER MEMORY. ALTHOUGH THERE IS EVIDENCE OF USE ERROR (PATIENT'S TESTING HEMATOCRIT LEVEL IS BELOW METER SPECIFICATIONS PER THE OWNER'S MANUAL), THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER ALLEGED THE PATIENT TOOK INSULIN DUE TO HIS PERCEIVED HIGH METER READING AND EXPERIENCED HYPOGLYCEMIA AND SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2544036

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R