BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243821 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03212
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. 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 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE PT TESTS HIS BLOOD GLUCOSE 4 TIMES A DAY. HE TESTS BEFORE MEALS AND AT BEDTIME. HE TAKES 20 UNITS OF NPH INSULIN IN THE MORNING AND 70-75 UNITS IN THE EVENING. HE ADJUSTS THE DOSAGES BASED ON HIS METER READINGS. THE PT ALSO TAKES HUMULIN-R INSULIN ON A SLIDING-SCALE BASED ON METER READINGS GREATER THAN 200 MG/DL. THE REPORTER CLAIMED THAT THE ALLEGED METER ISSUE STARTED THE DAY BEFORE AT 6:42 PM. AT THAT TIME, THE PT REPORTEDLY OBTAINED A "NORMAL" BLOOD GLUCOSE READING OF "153 MG/DL." AFTER TESTING, THE PT ADMINISTERED SELF-CARE BY TAKING 75 UNITS OF NPH INSULIN AT 6:45 PM. AT AROUND 7:00 PM, WHILE THE REPORTER AND PT WERE DRIVING TO GET DINNER, THE PT REPORTEDLY BEGAN TO FEEL SHAKY AND HAD TINGLING HANDS. THE REPORTER TREATED THE PT WITH A CANDY BAR. HOWEVER, THE PT STARTED TO BECOME UNRESPONSIVE WITHIN MINUTES. HE WAS UNABLE TO ANSWER THE REPORTER'S QUESTIONS. THE REPORTER DID NOT HAVE THE REPORTED METER WHILE THE PT WAS ASYMPTOMATIC. THE PARAMEDICS WERE CONTACTED. THEY TESTED THE PT WITH AN UNSPECIFIED DEVICE AND GOT A RESULT OF "37 MG/DL." THE PT WAS TREATED BY THE PARAMEDICS WITH IV GLUCOSE AND A SPOON OF GLUCOSE GEL. HE WAS TAKEN TO A HOSP WHERE HE REMAINED UNTIL AROUND MIDNIGHT THAT SAME EVENING. UPON ARRIVING IN THE HOSP, HIS BLOOD GLUCOSE REGISTERED AT "58 MG/DL" USING A HOSP METER. WHEN THE REPORTER GOT HOME, SHE PERFORMED A CONTROL SOLUTION TEST THAT PASSED. ACCORDING TO THE REPORTER, THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE METER WAS REPLACED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED, DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN. THE REPORTER ALSO ALLEGED THAT THE PT RECEIVED MEDICAL TREATMENT FROM PARAMEDICS DUE TO THE METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2836829

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R