BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2192385 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06908
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE ERRATIC ISSUE WITH HIS ONE TOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME ON (B)(6) 2011. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "180, 230 AND 150MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH PILLS, DIET AND/OR EXERCISE, AND DUE TO THE ALLEGED ISSUE HE WAS TAKING AN ADDITIONAL HALF DOSE OF AMARYL. THE PATIENT CLAIMED THAT A FEW HOURS AFTER TAKING THE EXTRA DOSE OF MEDICATION, HE FELT FAINT, WEAK, LIGHTHEADED AND SWEATY. HE REPORTEDLY TESTED AGAIN WHILE EXHIBITING THOSE SYMPTOMS AND GOT MORE INACCURATE HIGH READINGS (HE COULD NOT REMEMBER VALUES). HE INFORMED THIS MSS, THAT HE ASSOCIATED THOSE SYMPTOMS TO A LOW GLUCOSE LEVEL, AND KNEW THE METER WAS INACCURATE. THE PATIENT STATED THAT HE WENT AHEAD AND SELF TREATED WITH ORANGE JUICE OR GLUCOSE TABLETS TO FEEL BETTER. THE PATIENT REPORTED THAT ON (B)(6) 2011, AFTER GOING THRU THESE EVENTS SEVERAL TIMES, HE REALIZED HIS GLUCOSE MUST HAVE BEEN NORMAL AND WAS TREATING UNNECESSARILY WHICH WAS THEN DROPPING HIS GLUCOSE TOO LOW, AND SCHEDULED A DOCTOR'S APPOINTMENT FOR A CHECKUP. ACCORDING TO THE PATIENT HE WAS A TESTED WITH A CLINIC METER, BUT COULD NOT RECALL THE RESULT OBTAINED, AND NO MEDICATION ADJUSTMENTS WERE MADE OR NO FURTHER TREATMENT WAS NEEDED. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE, APPROPRIATE TESTING TECHNIQUE AND THE UNIT OF MEASURE WAS SET CORRECTLY IN THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3089990

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R