BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1063377 · Received June 19, 2008

    Report

    Report Number
    2939301-2008-01127
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 31, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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

    ON MAY 31, 2008 THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN/CLARIFY INFO. ON THE DAY BEFORE AT 9:30 PM, THE PT REPORTEDLY OBTAINED A READING OF 252 MG/DL ON THE LIFESCAN METER. DUE TO THE RESULT, THE PT CLAIMED SHE TOOK 9 UNITS OF HUMALOG INSULIN BASED ON HER PUMP READING. SHE IS UNABLE TO EXPLAIN HER PUMP'S BOLUS DOSING REGIMEN BUT SAYS HER AVERAGE BOLUS ADJUSTMENT IS ABOUT 4-5 UNITS. SHE CLAIMS THAT 9 UNITS IS MORE THAN SHE NORMALLY BOLUSES. ABOUT 5-10 MINS AFTER HER BOLUS DOSE, THE PT DEVELOPED SYMPTOMS OF SWEATINESS AND FELT VERY HOT. AT THIS TIME, SHE TESTED HER BLOOD SUGAR ON ANOTHER METER AND OBTAINED A RESULT OF 40 MG/DL. THE PT STATES SHE IS HYPOGLYCEMIC UNAWARE, WHICH MEANS SHE NORMALLY DOES NOT FEEL THE ONSET OF SYMPTOMS AND HER SYMPTOMS OCCUR VERY RAPIDLY AND SUDDENLY AS THEY DID THIS TIME. SHE TREATED THE SYMPTOMS BY ADMINISTERING A GLUCAGON INJECTION. SHE DOES NOT RECALL HOW LONG IT TOOK FOR HER TO GET BETTER BUT IN ADDITION TO THE INJECTION, SHE ATE PEANUT BUTTER AND DRANK ORANGE JUICE. THE PT TESTS HER BLOOD SUGAR 8-10 TIMES PER DAY AND ADMINISTERS A BOLUS DOSE 3 TIMES PER DAY. THE PT STATED SHE DID NOT EAT ANY LESS OR MORE PRIOR TO EXPERIENCING THE SYMPTOMS. IT WAS DETERMINED DURING THE TROUBLESHOOTING TELEPHONE CALL THE PT'S TESTING TECHNIQUE WAS CORRECT. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE RESULTS WERE VERIFIED IN THE METER MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE TOOK AN INCREASED DOSE OF INSULIN DUE TO THE ALLEGED INACCURATE HIGH READING, AND REPORTEDLY EXPERIENCED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2819137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R