BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1346440 · Received March 16, 2009

    Report

    Report Number
    2939301-2009-01885
    Event Type
    Injury
    Date Received
    March 16, 2009
    Report Date
    March 6, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 MARCH 6, 2009 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH AFTER HE HAD DROPPED THE METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON MARCH 13, 2009 TO OBTAIN/VERIFY THE FOLLOWING INFORMATION. THE PATIENT WAS UNABLE TO RECALL WHEN HE DROPPED THE METER BUT INDICATED THAT HE FIRST NOTICED THE INACCURACY ISSUE THE MONTH PRIOR. THE SAME DAY, THE PATIENT WOKE UP FEELING FAINT, SHAKY, SWEATY, AND THE "WHOLE NINE YARDS" OF HAVING A "DIABETIC EPISODE." HE TESTED ON HIS METER AND GOT A "170 MG/DL" RESULT. THE PATIENT DRANK SOME ORANGE JUICE AND FELT BETTER AFTERWARDS. HE FELT THAT THE "DIABETIC EPISODE" WAS A RESULT OF TAKING HIS HUMULIN THE NIGHT BEFORE. THE INSULIN WAS TAKEN APPROXIMATELY 7-8 HOURS BEFORE THE INCIDENT. HE RECALLED GETTING A "TYPICAL" BEFORE BEDTIME READING BEFORE TAKING HIS USUAL 20 UNITS OF HUMULIN. THE PATIENT STATED THAT HE TAKES THE SAME AMOUNT OF INSULIN EVERYDAY; HOWEVER, WOULD NOT TAKE HUMULIN IF HIS BLOOD GLUCOSE LEVELS GET BELOW 90 MG/DL. THE PATIENT HAS NOT CONSULTED HIS DOCTOR ABOUT THE INCIDENT AND DID NOT RECEIVE ANY OTHER FORMS OF TREATMENT. HE ALSO REPORTED "255, 191, 294, 300, 500 MG/DL" BLOOD GLUCOSE RESULTS FROM HIS METER, WHICH HE FELT WERE HIGH BECAUSE HE WAS NOT SYMPTOMATIC AT THE TIME OF THE TESTS. THE DATES/TIMES OF THESE READINGS WERE NOT SPECIFIED. HE DID NOT REPORT ANY INJURIES AS A RESULT OF THESE METER READINGS. THE PATIENT ALSO PERFORMED A COMPARISON WITH HIS OLD ONETOUCH ULTRA METER AND THE SUBJECT METER ON AN UNSPECIFIED DATE. THE RESULTS WERE "200 MG/DL" ON HIS OLD METER AND "299 MG/DL" ON THE SUBJECT METER, WHICH WERE OBTAINED WITHIN "MINUTES." THE CALCULATED DIFFERENCE BETWEEN THESE TWO RESULTS IS 50%, WHICH EXCEEDS THE EXPECTED VALUE OF <=30%. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS GETTING INACCURATE HIGH METER READINGS AND ALLEGEDLY BECAME HYPOGLYCEMIC. THE DIFFERENCE BETWEEN THE "200 AND 299 MG/DL" DID NOT MEET LIFESCAN'S CRITERIA. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2825412

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R