BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 657202 · Received December 13, 2005

    Report

    Report Number
    2939301-2005-05644
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Report Date
    December 4, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON DATE OF REPORT, THE LAY USER/REPORTER CONTACTED CO ALLEGING THE PT'S ONE TOUCH ULTRA METER WAS SET TO THE INCORRECT UNIT OF MEASUREMENT. THE (B)(4) CONTACTED THE PT TO OBTAIN AND VERIFY INFO. THE LAY USER/PT REPORTED THAT (B)(6) AGO HER BLOOD GLUCOSE WAS TESTED USING HER ONE TOUCH ULTRA METER AND THE RESULT OF 12.3 MMOL/L WAS OBTAINED. THE PT WAS EXPERIENCING NO SYMPTOMS OF HYPERGLYCEMIA. THE PT WAS UNABLE TO SPECIFY HOW LONG THE METER HAS BEEN IN THE MMOL/L UNIT OF MEASURE. THE PT REPORTED (B)(6) SHE HAD SEEN HER PHYSICIAN DUE TO HER BLOOD GLUCOSE RESULTS OF 333 MG/DL. THE PT'S BLOOD GLUCOSE WAS RETESTED IN THE PHYSICIAN'S OFFICE AND WAS IN THE 300'S; SPECIFIC RESULT UNK. AT THAT APPOINTMENT, THE PHYSICIAN GAVE THE PT AN INSULIN INJECTION; THE PT WAS UNABLE TO VERIFY THE TYPE OR QUANTITY OF INSULIN INJECTED. THE PT PURCHASED THE METER IN 2000 FROM A (B)(6), WHERE THE STORE PERSONNEL INITIALLY SET IT UP. THE PT WAS TAKING 2 PILLS OF METFORMIN TWICE PER DAY. IN 2002 OR 2003 THE PT STATES SHE STOPPED TAKING THE METFORMIN AND TESTING HER BLOOD GLUCOSE LEVELS. (B)(6) THE PT STARTED TAKING HER MEDICATION AGAIN. WITH HER PHYSICIAN'S KNOWLEDGE, SHE HAS REDUCED HER MEDICATION REGIMEN TO ONLY ONE PILL METFORMIN DAILY.

    Description of Event or Problem · 1

    ON DATE OF REPORT, THE LAY USER/REPORTER CONTACTED CO ALLEGING THE PT'S ONE TOUCH ULTRA METER WAS SET TO THE INCORRECT UNIT OF MEASUREMENT. THE SENIOR MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN AND VERIFY INFO. THE LAY USER/PT REPORTED THAT 2 DAYS AGO HER BLOOD GLUCOSE WAS TESTED USING HER ONE TOUCH ULTRA METER AND THE RESULT OF 12.3 MMOL/L WAS OBTAINED. THE PT WAS EXPERIENCING NO SYMPTOMS OF HYPERGLYCEMIA. THE PT WAS UNABLE TO SPECIFY HOW LONG THE METER HAS BEEN IN THE MMOL/L UNIT OF MEASURE. THE PT REPORTED LAST MONTH SHE HAD SEEN HER PHYSICIAN DUE TO HER BLOOD GLUCOSE RESULTS OF 333 MG/DL. THE PT'S BLOOD GLUCOSE WAS RETESTED IN THE PHYSICIAN'S OFFICE AND WAS IN THE 300'S; SPECIFIC RESULT UNK. AT THAT APPOINTMENT, THE PHYSICIAN GAVE THE PT AN INSULIN INJECTION; THE PT WAS UNABLE TO VERIFY THE TYPE OR QUANTITY OF INSULIN INJECTED. THE PT PURCHASED THE METER IN 2000 FROM A MEDICAL SUPPLY STORE, WHERE THE STORE PERSONNEL INITIALLY SET IT UP. THE PT WAS TAKING 2 PILLS OF METFORMIN TWICE PER DAY. IN 2002 OR 2003 THE PT STATES SHE STOPPED TAKING THE METFORMIN AND TESTING HER BLOOD GLUCOSE LEVELS. LAST MONTH THE PT STARTED TAKING HER MEDICATION AGAIN. WITH HER PHYSICIAN'S KNOWLEDGE, SHE HAS REDUCED HER MEDICATION REGIMEN TO ONLY ONE PILL METFORMIN DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2596950

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR