BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1092804 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01614
    Event Type
    Injury
    Date Received
    July 31, 2008
    Report Date
    July 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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

    THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT THE PT'S ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT OR HIS DAUGHTER AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE DAUGHTER REPORTED THAT ON THE SAME DAY AT 5:00 PM, THE PT HAD OBTAINED A RESULT OF 89 MG/DL ON THE SUBJECT METER. AS A RESULT OF THE REPORTED ISSUE/RESULT, HE DID NOT TAKE ANY ACTIONS. HE THEN REPORTEDLY STARTED NOT FEELING GOOD (DISORIENTED, SHAKY, NO MUSCLE CONTROL, AND ALMOST FAINTING). BETWEEN 5:00-5:15 PM, SHE CLAIMED THAT THE EMERGENCY SERVICES WERE CALLED AND THE RESULT ON THE EMT METER WAS REPORTEDLY 33 MG/DL. THE PT WAS GIVEN ORAL GLUCOSE AND TAKEN TO THE HOSPITAL. AT THE HOSPITAL, HIS BLOOD GLUCOSE RESULT ON THE HOSPITAL METER WAS REPORTEDLY 117 MG/DL AND ON THE SUBJECT METER WAS 127 MG/DL. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). THE PT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND HE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRATION/DISCARD DATES. THE METER WAS ALSO CODED CORRECTLY TO MATCH THE CODE ON THE TEST STRIP VIAL. THE PT WAS WALKED THROUGH TWO CONTROL SOLUTION TESTS AND THEY PASSED WITHIN RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DAUGHTER CLAIMED THAT THE PT EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. WITHIN 15 MINUTES OF THE ALLEGED HIGH RESULT, THE PT WAS REPORTEDLY TREATED WITH ORAL GLUCOSE BY THE PARAMEDICS. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2810977

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R