BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1020936 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00399
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    February 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATED THEM AND, EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON FEBRUARY 29, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER READ INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST (MAS) CALLED THE PATIENT ON MARCH 20, 2008, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY. HE TESTS BEFORE EACH MEAL. HIS NORMAL BLOOD GLUCOSE LEVELS ARE AROUND "150 MG/DL." THE PATIENT TAKES HUMULIN 70/30 INSULIN ON A SLIDING-SCALE BASED ON HIS METER READINGS. THE PATIENT INDICATED THAT THE METER ISSUE BEGAN APPROXIMATELY 10 DAYS PRIOR TO CALLING LFS ON FEBRUARY 29, 2008. THE PATIENT REPORTED METER RESULTS OF "295 AND 320 MG/DL." HOWEVER, HE COULD NOT RECALL WHAT TIMES THE READINGS WERE OBTAINED. BASED ON THE METER READINGS, THE PATIENT TOOK AN UNSPECIFIED DOSE OF SLIDING-SCALE HUMULIN 70/30 INSULIN. AN UNKNOWN TIME LATER THAT DAY, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY AND DIZZY. HE ADMINISTERED SELF-CARE BY DRINKING ORANGE JUICE RIGHT AWAY, SINCE HE KNEW HIS BLOOD GLUCOSE WAS LOW. HE WAS UNABLE TO RECALL IF HE TESTED HIS BLOOD GLUCOSE WHILE HE WAS SYMPTOMATIC. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER AND WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED, THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER INACCURACY OCCURRED. THE PATIENT WAS ABLE TO TREAT HIMSELF PROPERLY BY DRINKING ORANGE JUICE TO RAISE HIS BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2737902

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R