BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1511436 · Received October 15, 2009

    Report

    Report Number
    2939301-2009-06362
    Event Type
    Injury
    Date Received
    October 15, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 1, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    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

    ON OCTOBER 1, 2009, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE REPORTER ON OCTOBER 7, 2009, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE PATIENT MANAGES HIS DIABETES WITH SLIDING-SCALE HUMULIN 70/30 INSULIN BASED ON HIS METER READINGS. THE REPORTER INDICATED THAT THE ALLEGED ISSUE BEGAN ON THE DAY OF EVENT AT 12:22 PM. AT THAT TIME, THE PATIENT OBTAINED A RESULT OF "233 MG/DL." RESULTS OF "191, 233, 244, AND 233 MG/DL" WERE VERIFIED IN THE REPORTED METER'S MEMORY. BASED ON THE METER READING OF "233 MG/DL," THE PATIENT TOOK 40 UNITS OF HUMULIN 70/30 INSULIN BASED ON HIS SLIDING-SCALE REGIMEN AT 12:30 PM. AN UNSPECIFIED TIME LATER THAT DAY, THE REPORTER CLAIMED THAT THE PATIENT DROPPED LOW AND HAD SYMPTOMS OF DIZZINESS, CONFUSION, AND SWEATY SKIN. THE PATIENT TESTED HIS BLOOD GLUCOSE WHILE FEELING LOW AND GOT "80 SOMETHING." ACCORDING TO THE REPORTER, THE PATIENT EXPECTED A BLOOD GLUCOSE READING THAT WAS LOWER. HE FELT AS THOUGH THE RESULT OF "80 SOMETHING" WAS STILL TOO HIGH COMPARED TO HOW HE FELT. THE PATIENT ADMINISTERED SELF-TREATMENT BY EATING A SANDWICH AND DRINKING JUICE. HE FELT BETTER AFTER THE SELF-CARE WAS TAKEN. ACCORDING TO THE REPORTER, THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A METER READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2955423

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R