BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1984134 · Received February 10, 2011

    Report

    Report Number
    2939301-2011-01276
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    February 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K053529. 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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT HE WAS ADMITTED IN THE HOSPITAL FOR SEVERAL VARIOUS EXAMS WHICH WAS ORDERED BY HIS PHYSICIAN. THE PATIENT WAS ADMITTED FROM (B)(6) 2011. WHILE HE WAS THERE HE COMPARED HIS METER ONE TOUCH ULTRA 2 METER TO THE HOSPITAL DEVICES. HE ALSO MENTIONED THAT A WEEK PRIOR TO GOING TO THE HOSPITAL HE HAD TESTED SEVERAL TIMES AND OBTAINED HIGH READINGS AND LATER DEVELOPED SYMPTOMS OF "HYPOGLYCEMIA", WHERE HE EXPERIENCED BLURRED VISION AND WEAKNESS. HE DOES NOT RECALL THE EXACT DATES, TIMES OR BLOOD GLUCOSE READINGS, SINCE HIS METER IS WITH THE NURSE. HE CLAIMS WHEN HE EXHIBITED THESE SYMPTOMS, HE SELF-TREATED HIMSELF WITH BREAD AND THEN LAY DOWN IN A RESTING POSITION. HIS SYMPTOMS LASTED FOR ABOUT 30 MINUTES AND HE DID NOT ATTEMPT TO RETEST SINCE HE FELT BETTER AFTER EATING AND RESTING. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PATIENT MENTIONED THAT ON (B)(6) 2011, HIS SECOND DAY IN THE HOSPITAL, HE FELT WEAK IN THE MORNING. HE TESTED ON HIS ULTRA 2 METER AND OBTAINED A 90 MG/DL AND HE STILL WAS NOT FEELING WELL AND HAD ASKED THE NURSE TO TEST HIS BLOOD GLUCOSE USING THEIR METER AND OBTAINED A 31 MG/DL. THE NURSE TREATED HIM WITH BREAD AND JUICE AND ADVISED HIM TO REST. AT 8:55AM, ON (B)(6) 2011, THE PATIENT OBTAINED A 55 MG/DL ON THE HOSPITAL'S DEVICE AND RESULT OVER 100 MG/DL ON HIS ONE TOUCH ULTRA 2 METER. THE PATIENT WAS TREATED WITH BREAD AND JUICE. THERE IS NO INFORMATION ON WHETHER THE PATIENT EXHIBITED ANY SYMPTOMS AT THIS TIME. A T NOON, THE READING AGAIN ON THE HOSPITAL WAS 55 MG/DL AND HIS ULTRA 2 METER 93 MG/DL. HE WAS TREATED AGAIN WITH BREAD AND JUICE. THERE IS NO INFORMATION ON WHETHER THE PATIENT EXHIBITED ANY SYMPTOMS AT THIS TIME. AT 2:30PM, THE PATIENT OBTAINED A 31 MG/DL ON THE HOSPITAL DEVICE AND A 94 MG/DL ON HIS ULTRA 2 METER. HE WAS TREATED WITH BREAD AND JUICE. THERE IS NO INFORMATION ON WHETHER THE PATIENT EXHIBITED ANY SYMPTOMS AT THIS TIME. THE NURSE REPLACED HIS ULTRA 2 METER AND GAVE HIM AN ULTRA EASY METER. PATIENT WAS DISCHARGED ON (B)(6) 2011 AND PER THE PATIENT THE DIAGNOSIS WAS PROBLEMS WITH THE KIDNEYS WERE "DAMAGED". A NORMAL RANGE FOR HIM IS BETWEEN 180-200 MG/DL LFS REQUESTED THE SUBJECT METER BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READINGS, HE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD AND FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3040818

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R