BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAMINI

    MDR report key: 1001989 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00207
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008 AT 9:13 PM PT, A PATIENT/LAYPERSON INFORMED A CUSTOMER CARE ADVOCATE OF HER CONCERN THAT AN INSULIN REACTION EARLIER THE SAME DAY WAS DUE TO TAKING EXTRA INSULIN BASED UPON AN INACCURATELY HIGH BLOOD GLUCOSE RESULT ON HER ONE TOUCH ULTRAMINI. AN EMERGENCY MEDICAL TEAM TREATED THE PATIENT. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT ON TEN DAYS LATER, WHO PROVIDED THE FOLLOWING. RESULTS ARE IN MG/DL, CORRECT UNIT OF MEASURE. PRIOR TO THE EVENT, THE PATIENT'S BLOOD GLUCOSE RESULTS WERE USUALLY IN THE 200 MG/DL RANGE BEFORE BREAKFAST AND THROUGHOUT THE DAY. ON ORIGINAL DATE, THE 7:00 AM FASTING WAS AROUND 200. THE PATIENT ATE A "SMALL BREAKFAST" AND TOOK THE USUAL 20 UNITS OF N INSULIN. AT 9:00 AM, BLOOD GLUCOSE WAS IN THE 300'S. AT LUNCH, THE PATIENT DID NOT EAT BECAUSE OF THE PRIOR ELEVATED RESULT. THE PATIENT HAD NO SYMPTOMS AND NORMALLY HAS NONE WHEN IT IS ELEVATED. AT SOME POINT, THE PATIENT COMPARED A RESULT OF 315 ON HER METER TO ONE OF 140 ON ANOTHER PERSON'S METER. AFTER OBTAINING 311 ON HER METER, POSSIBLY BETWEEN 2 AND 2:30 PM ET, THE PATIENT TOOK 15 UNITS OF HUMULIN R BASED UPON A SLIDING SCALE. SOON AFTER TAKING THE INSULIN, HER SON CALLED. BECAUSE HE THOUGHT SHE WAS HYPERVENTILATING, HE IMMEDIATELY CAME TO HER HOME. THE PATIENT WAS ALSO "NUMB, SHAKY, DIZZY, AND UNABLE TO WALK." HE CALLED THE EMT WHO ARRIVED 20 MINUTES LATER. NO TEST WAS PERFORMED BEFORE EMT ARRIVED. AFTER A RESULT OF 30 ON THE EMT METER, THE PATIENT WAS TREATED WITH A SHOT OF GLUCOSE AND GIVEN ORANGE JUICE WITH SUGAR ADDED. THE PATIENT REFUSED TO BE TAKEN TO HOSPITAL, SINCE THE EVENT, THE PATIENT'S DOCTOR CHANGED THE INSULIN REGIME. NOW SHE TAKES ONLY HUMULIN N, NO R. IT WAS ALSO LEARNED AFTER THE PATIENT RECEIVED THE NEW METER AND TEST STRIPS THAT THE SUBJECT METER WAS SET TO CODE 17 WHILE THE TEST STRIPS WERE CODE 9. THE PATIENT RECALLS, IT WAS ON CODE 17 BUT IS CERTAIN THE METER "JUMPED BACK TO CODE 9." A METER SET TO THE WRONG CODE CAN CAUSE THE METER TO PROVIDE INCORRECT BLOOD GLUCOSE RESULTS. THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT. THE PATIENT CLAIMED SHE INJECTED EXTRA SHORT ACTING INSULIN AFTER AN ELEVATED READING THAT RESULTED IN INTERVENTION BY EMT FOR HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2767029

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R