BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1912146 · Received December 2, 2010

    Report

    Report Number
    2939301-2010-10420
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS THREE TIMES A DAY AND MANAGES HIS DIABETES WITH 6 UNITS OF HUMALOG INSULIN (WITH EVERY MEAL) AND HUMULIN N INSULIN (52 UNITS IN THE MORNING AND 42 UNITS IN THE EVENING). THE PATIENT INDICATED THE ISSUE OCCURRED SEVERAL DAYS PRIOR TO CONTACTING LFS (AT 3AM); THE PATIENT, HOWEVER, DOES NOT RECALL THE DATE. THE PATIENT CONFIRMED HE OBTAINED A BLOOD GLUCOSE RESULT OF "130MG/DL" WITH THE SUBJECT METER AND MORE THAN 30 MINUTES LATER, HE OBTAINED A POSSIBLE BLOOD GLUCOSE RESULT OF "75MG/DL" WITH THE EMERGENCY MEDICAL SERVICE'S (EMS) METER. A FEW MINUTES PRIOR TO THE ALLEGED ISSUE, THE PATIENT CLARIFIED HE WOKE UP WITH SYMPTOMS OF CONFUSION, PERSPIRATION, AND COULD NOT SPEAK WELL. THE PATIENT DOES NOT RECALL WHAT HIS BLOOD GLUCOSE RESULT WAS PRIOR TO GOING TO BED; HOWEVER STATED HE ADMINISTERED HIS USUAL EVENING DOSE OF HUMULIN N INSULIN. IN RESPONSE TO THE PATIENT'S SYMPTOMS, THE PATIENT CLARIFIED HIS WIFE CONTACTED THE EMS AND SOMETIME BETWEEN 3:30-4AM, THE EMS ARRIVED. THE PATIENT, HOWEVER, DOES NOT RECALL IF HE SELF-TREATED HIS SYMPTOMS PRIOR TO THE EMS ARRIVING. THE PATIENT CONFIRMED HE RECEIVED A GLUCAGON INJECTION AS TREATMENT BY THE HEALTH CARE PROFESSIONAL (HCP). THE PATIENT'S BLOOD GLUCOSE RESULTS POST TREATMENT WITH THE EMS'S METER OR THE SUBJECT METER ARE NOT KNOWN. THE PATIENT STATED HE WAS NOT TRANSPORTED TO THE HOSPITAL. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT INDICATED THAT DURING A DOCTOR'S OFFICE VISIT (DATE UNKNOWN) HIS PHYSICIAN ADJUSTED HIS EVENING REGIMEN TO 27 UNITS. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL) AND THE BLOOD GLUCOSE RESULT WAS FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043216

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention