BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1556864 · Received December 8, 2009

    Report

    Report Number
    2939301-2009-07486
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    November 24, 2009
    Report Date
    November 24, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING THE ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DOCUMENTATION. THE REPORTER SAID THAT ABOUT 10 DAYS BEFORE CALLING LIFESCAN, THE PT STARTED TO HAVE HIGHER THAN NORMAL BLOOD SUGAR VALUES. THE PT THEN MADE AN APPOINTMENT WITH A GENERAL PRACTITIONER TO GET A CHECK UP TO SIX DAYS LATER, IN THE MORNING. THE REPORTER SAID THAT THE PHYSICIAN ADJUSTED THE PT'S MEDICATION REGIME BASED ON THE HIGH METER READINGS AND PRESCRIBED AN EXTRA 2 TABLETS OF AMARYL IN A DAY. HE KEPT HIS INSULIN DOSE THE SAME. THE PT TAKES 12 UNITS OF AN UNK TYPE OF INSULIN IN THE MORNING AND AT LUNCH AND TAKES 8 UNITS IN THE EVENING. THE REPORTER ALLEGED THE PT WOKE UP JUST BEFORE 6:18 AM ON EVENT DATE, BEING PALE AND HAVING SHAKING LEGS. THE REPORTER ALLEGES THESE SYMPTOMS ARE INDICATIVE OF HYPOGLYCEMIA FOR THE PT. THREE READINGS WERE TAKEN AT THAT TIME ON THE PT'S METER AND THE REPORTED RESULTS WERE 173, 271, AND 278 MG/DL. THE REPORTER SAID, SHE KNOCKED ON THE NEIGHBOR'S DOOR TO OBTAIN ANOTHER METER. WHEN TESTING THE PT'S BLOOD SUGAR ON THE OTHER METER THE RESULT WAS ALLEGEDLY 57 MG/DL AT THE SAME TIME THE PT FELT SYMPTOMS. THE REPORTER GAVE THE PT SOME JAM AND A PIECE OF CAKE AND SAID, IT TOOK THE PT 8 MINUTES TO RECOVER AFTER INGESTING THE FOOD. THE PT TESTS HIS BLOOD SUGAR THREE TIMES PER DAY. THE REPORTER GAVE VARIOUS RESULTS SUCH AS "115, 110, 168, 143, 111, 106, 207, AND 155 MG/DL" IN THREE DAYS, "88, 91, AND 169 MG/DL" AND "173, 271, 278, 175, AND 158 MG/DL". IT WAS DETERMINED THAT THE PT'S TESTING STEPS WERE CORRECT. THE UNIT OF MEASUREMENT WAS SET CORRECTLY AT THE TIME OF TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGED THAT THE METER READ INACCURATELY HIGH, THAT THE PT'S DOCTOR INCREASED THE PT'S MEDICATION REGIME BASED ON THE RESULTS AND THAT THE PT SUFFERED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2958526

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Life Threatening| R