BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1032063 · Received April 18, 2008

    Report

    Report Number
    2939301-2008-00594
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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 FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER 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 THE PATIENT'S ONE TOUCH ULTRA METER. A MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED ON EIGHT DAYS EARLIER AT 7:00 AM, HE TESTED HIS BLOOD GLUCOSE AND OBTAINED A 356 MG/DL. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS. SINCE LATE 2007, HIS READINGS HAVE BEEN VERY ERRATIC. HIS BLOOD GLUCOSE VARIES FROM 90 MG/DL TO 480 MG/DL; THEREFORE, HE WAS NOT ALARMED WHEN HE OBTAINED THE RESULT OF 356 MG/DL. HE TOOK 46 UNITS OF ACTRAPID INSULIN BASED ON A SLIDING SCALE. THE PATIENT ALSO TOOK HIS SET AMOUNT OF LANTUS (36 UNITS) AND THEN ATE BREAKFAST. THE PATIENT DOES NOT REMEMBER WHAT HE ATE FOR BREAKFAST THE DAY OF THE INCIDENT. AT AROUND 9:00 AM, THE PATIENT BEGAN TO EXHIBIT SYMPTOMS, WHICH CONSISTED OF FEELING SWEATY AND SHAKY. HE IMMEDIATELY TOOK DEXTROSE AND DRANK APPLE JUICE. HE DID NOT TEST HIS BLOOD GLUCOSE AT THE TIME OF EXHIBITING SYMPTOMS. HE FELT BETTER ABOUT 15 MINUTES LATER, AND THEN WENT TO HIS PHARMACY AND TOLD THEM WHAT HAD HAPPENED. THE PHARMACIST PROVIDED THE PATIENT WITH ANOTHER BRAND OF METER AND ADVISED THE PATIENT TO CONTACT LFS. AROUND NOON, THE SAME DAY THE PATIENT TESTED HIS BLOOD GLUCOSE AND OBTAINED A 324 MG/DL, AT 6:00 PM A 401 MG/DL AND AT 10:00 PM A 207 MG/DL AND DID NOT EXHIBIT ANY SYMPTOMS WITH ANY OF THE ELEVATED READINGS. AT AN UNSPECIFIED DATE AND TIME, THE PATIENT COMPARED HIS ONE TOUCH ULTRA METER ONCE OR TWICE WITH THE OTHER NEW METER AND CLAIMS THAT HIS ULTRA READINGS WERE 60 MG/DL HIGHER THAN THE OTHER METER. THE PATIENT DID NOT RECALL THE READINGS ON EITHER DEVICES. THE PATIENT TESTS FOUR TIMES A DAY. THE PATIENT HAD MADE AN APPOINTMENT WITH HIS PHYSICIAN TO ADJUST HIS DIABETES MEDICATION. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE, SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT CLAIMED HE TOOK INSULIN BASED ON THE METER RESULT, TWO HOURS LATER DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AND FELT BETTER SOON AFTER SELF-TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R