BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081634 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01471
    Event Type
    Other
    Date Received
    July 22, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND TEST STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE METER AND TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE METER OR TEST STRIP DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) IN 2008 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRA 2 METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: TWO DAYS PRIOR AT 7:54 PM, THE PATIENT REPORTEDLY OBTAINED A 159 MG/DL AND DID NOT EXHIBIT ANY SYMPTOMS. BASED ON THE METER RESULT, HE INJECTED 26 UNITS OF ACTRAPID INSULIN. THE PATIENT ALWAYS WAITS 30-45 MINUTES AFTER TAKING THE INSULIN TO EAT DINNER. BETWEEN 8:30 PM-9:00PM, THE PATIENT WENT INTO THE KITCHEN TO GET READY TO EAT DINNER AND HAD FALLEN UNCONSCIOUS IN THE KITCHEN, AND HIS NEIGHBOR FOUND HIM A FEW MINUTES LATER AND CONTACTED THE PARAMEDICS. PRIOR TO THE PARAMEDICS ARRIVING, THE REPORTER TRIED TO TREAT THE PATIENT WITH GRAPE WATER; HOWEVER, WAS UNSUCCESSFUL AND DID NOT ATTEMPT TO TEST HIS BLOOD GLUCOSE. PARAMEDICS ARRIVED AND TESTED THE PATIENT USING THEIR METER AND REPORTEDLY OBTAINED A READING AROUND 40-50 MG/DL. THE PATIENT WAS TREATED WITH GLUCOSE INTRAVENOUSLY AND FELT BETTER SOON AFTER. THE PATIENT DID NOT RECEIVE ANY FURTHER MEDICAL INTERVENTION AND WAS NOT TAKEN TO THE HOSPITAL. THE PATIENT DOES NOT KNOW HOW LONG THE PARAMEDICS STAYED AT HIS HOME; HOWEVER, CLAIMS THAT THEY TESTED THE PATIENT PRIOR TO LEAVING (IT IS UNKNOWN ON WHOSE METER THEY TESTED HIS BLOOD GLUCOSE) AND OBTAINED A 115 MG/DL. AT 9:32 PM, THE SAME DAY, THE PATIENT TESTED HIS BLOOD GLUCOSE AND OBTAINED A 124 MG/DL ON HIS OWN METER. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE, SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. A NORMAL BLOOD GLUCOSE READING FOR THE PATIENT IS REPORTEDLY BETWEEN 100-140 MG/DL. THE PATIENT TESTS HIS BLOOD GLUCOSE 6-7 TIMES A DAY. THE PATIENT HAS BEEN DIABETES FOR MORE THAN 20 YEARS. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS HE TOOK INSULIN BASED ON THE ALLEGED INACCURATE METER RESULT, AND REPORTEDLY BECAME HYPOGLYCEMIC AFTER THE REPORTED 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 2847604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R